Systems, Methods, and Apparatus for Resuspending Cells from Surgical Laundry

ABSTRACT

Systems, apparatus, methods, and articles of manufacture provide for resuspending and/or collecting blood or other types of cells from used surgical sponges and/or other types of surgical articles.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of priority of U.S.Provisional Patent Application No. 61/861,953 filed Aug. 2, 2013,entitled “SPONGE WASHING SYSTEM,” which is incorporated by reference inthe present application.

BRIEF DESCRIPTION OF THE DRAWINGS

An understanding of embodiments described in this disclosure and many ofthe related advantages may be readily obtained by reference to thefollowing detailed description when considered with the accompanyingdrawings, of which:

FIG. 1 is a block diagram of a cell resuspension system according to oneor more embodiments;

FIG. 2 is a cross-section view of a cell resuspension tub systemaccording to one or more embodiments;

FIG. 3 is a cross-section view of a cell resuspension system accordingto one or more embodiments;

FIG. 4 is a top view of a cell resuspension system according to one ormore embodiments;

FIG. 5 is a top view of a cell resuspension agitator device according toone or more embodiments;

FIG. 6 is a top view of a cell resuspension agitator device according toone or more embodiments;

FIG. 7 is a perspective view of a cell resuspension system according toone or more embodiments;

FIG. 8 is a front view of a cell resuspension system according to one ormore embodiments;

FIG. 9 is a side view of a cell resuspension system according to one ormore embodiments;

FIG. 10 is a side view of a cell resuspension system according to one ormore embodiments;

FIG. 11 is a top view of an occlusion clamp assembly according to one ormore embodiments;

FIG. 12 is a perspective view of an example connector of a cellresuspension tub system, according to one or more embodiments;

FIG. 13 is a perspective view of an example connector of an agitatordevice, according to one or more embodiments;

FIG. 14 is a perspective view of an example connector of a cellresuspension tub system coupled with an example connector of an agitatordevice, according to one or more embodiments;

FIG. 15 is a perspective view of an example connector of an agitatordevice, according to one or more embodiments, for connecting to a cellresuspension tub system;

FIG. 16 is a cross-section view of a cell resuspension tub systemaccording to one or more embodiments;

FIG. 17 is a cross-section view of a cell resuspension tub systemaccording to one or more embodiments;

FIG. 18 is a flowchart of a method according to one or more embodiments;and

FIG. 19 is a diagram of an example user interface according to one ormore embodiments.

DETAILED DESCRIPTION A. Introduction

Applicants have recognized that, in accordance with some embodimentsdescribed in this disclosure, some types of medical professionals andother types of users (e.g., autotransfusion specialists, nurses,perfusionists, surgeons, and other types of medical professionals) mayfind it beneficial to reclaim, recover, and/or resuspend blood and othertypes of body cells of a patient from various types of surgicalarticles. In one embodiment, resuspended blood may be stored forre-infusion and/or re-infused to a patient (e.g., during a currentmedical procedure).

Applicants have further recognized that, in accordance with someembodiments described in this disclosure, rinsing and/or soakingsurgical sponges and other types of surgical laundry with physiologicsuspension solution may dilute coagulation components of whole blood,thereby making clotting of the blood in the laundry and/or in a cellsaver less likely, yielding more salvageable blood from the laundry.Applicants have further recognized that, in accordance with someembodiments described in this disclosure, by rinsing and/or soakingsurgical laundry the laundry may become saturated with suspension fluid,further liberating blood (e.g., from woven cotton fibers). Applicantshave further recognized that, in accordance with some embodimentsdescribed in this disclosure, one or more types of medications,surfactants, antibiotics, and/or other agents (e.g., anticoagulantcitrate phosphate dextrose (CPD) solution, heparin, albumin) may beadded directly to soaking tub or to a physiologic solution to increasethe yield of blood retrieved from surgical articles and/or to increasethe viability of recovered blood.

Applicants have further recognized that, in accordance with someembodiments described in this disclosure, in may be advantageous toprovide for a cell reclamation system, method, and apparatus providingfor and/or utilizing one or more of: normothermic blood (e.g., at 98.6Fand/or allowing for normal oxygen unloading); automation of one or moresteps of cell reclamation; increased viability of recovered blood bydilution of the blood in a suspension fluid; improved determination andmonitoring of an indication of a volume of blood lost to sponges andother surgical laundry; determining and storing an indication of thenumber of cycles undertaken in a cell reclamation process; a cellreclamation apparatus that is closed to the environment and/or reducesrisks of splatter and/or airborne contamination; and/or automaticallysending blood-laden suspension fluid to a cell saver without disruptionof any ongoing cell saver field collection.

In accordance with one or more embodiments of the present invention,systems, methods, apparatus, and articles of manufacture are describedthat provide for one or more of the following functions: liberating,reclaiming, releasing, retrieving, extracting, recovering, resuspending,and/or collecting blood or other types of cells from used surgicalsponges and/or other types of surgical articles (e.g., that absorbed,came into contact with, received, and/or were used to collect or cleanup blood during a surgical procedure); warming physiologic fluid to adesired temperature or temperature range (e.g., a normothermictemperature); transmitting physiologic fluid to a tub or other vesselfor use in extracting (e.g., by soaking and/or agitating) cells fromsurgical articles (e.g., surgical sponges placed in a vessel by anoperator at a surgical field); adding one or more types of agents to aphysiologic fluid (e.g., for increasing the yield and/or viability ofrecovered cells); soaking one or more surgical articles in a physiologicsolution; suspending recovered blood in a physiologic suspensionsolution; and/or preparing recovered blood for re-infusion to a patient(e.g., using a cell saver or other type of autologous cell salvagedevice).

In accordance with one or more embodiments of the present invention,systems, methods, apparatus, and articles of manufacture are describedthat provide for an automated device configured to extract blood fromsurgical sponges and to re-suspend that blood at an approximatelynormothermic temperature in a physiologic solution for processing by anautotransfusion device (e.g., a cell saver). In some embodiments, adevice is configured to liberate blood from bloody surgical sponges andprepare the reclaimed blood for processing (e.g., by an autologous cellsalvage device) for re-infusion to a patient. In one embodiment, thedevice warms a physiologic fluid to a normothermic temperature (and/orreceives a warmed physiologic fluid), transmits the warmed physiologicfluid to a vessel for soaking surgical sponges used to collect blood,and, in accordance with an automated process, recovers and resuspendsthe blood form the surgical sponges into a physiologic suspensionsolution.

In accordance with one or more embodiments of the present invention,systems, methods, apparatus, and articles of manufacture are describedthat provide for a reusable agitator device and a disposable, single-usetub system, including a soaking tub and a tubing set, for use with thereusable agitator device.

B. Definitions

The terms “cell resuspension tub” and “soaking tub” may be usedsynonymously in this application to refer to a tub, drum, or other typeof vessel used for holding surgical articles (e.g., surgical laundry)and/or fluid (e.g., for resuspending cells from the surgical laundry ina fluid solution). In accordance with some embodiments, a cellresuspension tub may be spun, rotated, vibrated, shaken, and/orotherwise agitated. In some embodiments, a cell resuspension tub mayrefer to a vessel comprising, connected to, and/or coupled with one ormore components such as, without limitation, one or more fins, sensors,heaters, and/or connectors (e.g., for coupling the vessel to a motor orother agitator device).

The term “cell resuspension tub system” may be used in this applicationto refer to a cell resuspension tub and one or more other types ofcomponents with which the cell resuspension tub may be connected,coupled, manufactured, packaged, marketed, and/or sold (e.g., as asterile kit). In some embodiments, a cell suspension tub and/or one ormore other components may be sterile, disposable, and/or intended foronly one use. Components of a cell resuspension tub system may comprise,by way of example and not limitation, one or more of: tubing, fluid, apump, a sensor, and/or a heater, etc. In accordance with someembodiments, a sterile, single-use, disposable cell resuspension tubsystem comprising a soaking tub, inlet tubing for filling the soakingtub with fluid, and outlet tubing for emptying the soaking tub, may bereferred to as a “tub kit.”

The terms “cell resuspension agitator device” and “agitator device” maybe used synonymously in this application to refer to anyelectro-mechanical device configured to agitate a cell suspension tub(e.g., to assist in forcing and/or drawing out cells captured insurgical laundry and into a suspending solution). In some embodiments, acell resuspension agitator device may comprise a motor configured to becoupled to a soaking tub. In some embodiments, a cell resuspensionagitator device may comprise means for agitating a soaking tub and oneor other components (e.g., sensors, displays, etc.) and/or controllersfor controlling one or more functions of a cell resuspension process. Inone or more embodiments, a cell resuspension agitator device may beembodied as and/or embodied in an integrated cell resuspension appliancethat also includes software and/or hardware controllers for variousaspects of a cell resuspension process.

The terms “cell resuspension controller device” and “controller device”may be used synonymously in this application to refer to anyelectro-mechanical device configured for controlling one or morefunctions of a cell resuspension process (e.g., filling a tub and/oremptying a tub; pumping, heating, monitoring, sensing, and/or measuringfluid, etc.). In one example, a controller device may comprise acomputing device (e.g., a personal computer, a table computer) connectedto an agitator device for controlling agitation of a soaking tub and toa fluid intake/output system for controlling the filling and emptying ofthe soaking tub. In one or more embodiments, a cell resuspensioncontroller device may be embodied as and/or embodied as a single unit orappliance as an integrated cell resuspension appliance configured toreceive one or more components (e.g., tubing) of a cell resuspension tubsystem and also including an agitator device for agitating a cellresuspension tub when the tub is connected to the integrated cellresuspension appliance.

The term “cell resuspension system” may be used in this application torefer to any combination of two or more of: a cell resuspension tub, acell resuspension tub system, a fluid system (e.g., tubing, fluid,and/or a pump), a sensor, an agitator device, a controller device, anintegrated cell resuspension appliance, and/or a cell saver. In oneexample, a cell resuspension system may comprise a soaking tub coupledto a motor. In one or more embodiments, a cell resuspension system maycomprise a cell resuspension tub system and an integrated cellresuspension appliance. In some embodiments, a cell resuspension systemmay comprise a sterile, disposable tub kit including a soaking tub andintake and/or output fluid systems, and a reusable, integrated cellresuspension appliance (e.g., to which the soaking tub and fluidsystem(s) are connected for resuspending cells from surgical laundry).

The term “surgical sponge” may be used in this application to refer to atype of surgical laundry typically made of a woven cotton or other meshmaterial and designed to capture fluids (e.g., blood) that may leak froma body (e.g., during a surgical procedure). Some examples of surgicalsponges include, without limitation, laparotomy sponges, lap pads, gauzepads, swabs, and X-ray detectable sponges.

C. General Systems and Structures

FIG. 1 depicts a block diagram of an example architecture for a cellresuspension system 100 for facilitating the resuspension of cells fromsurgical laundry and other articles, according to one or moreembodiments. The cell resuspension system 100 may include a memoryinterface 102, one or more data processors, image processors, and/orcentral processing units 104, and a controller interface 106. The memoryinterface 102, the one or more processors 104, and/or the controllerinterface 106 may be separate components or may be integrated in one ormore integrated circuits. The various components in the cellresuspension system 100 may be coupled by one or more communicationbuses or signal lines.

Sensors, devices, and subsystems may be coupled to the controllerinterface 106 to facilitate multiple functionalities. For example, aflow/air detector 109, a temperature sensor 110, a heater 112, a pump114, a fill sensor 116, a hematocrit sensor 118, and a motor 120 may becoupled to the controller interface 106 to facilitate heating, filling,monitoring, suspending, and/or draining functions described in thisdisclosure with respect to various embodiments.

In some embodiments, as discussed in this disclosure, the motor 120 maybe configured (e.g., via a drive shaft and/or connector) to agitate acell resuspension tub containing fluid and surgical laundry and/or othersurgical articles (not shown), and the motor 122 (which may be embodiedas an agitator device) may receive controlling signals via thecontroller interface 106. As discussed in this disclosure, one or moretemperature sensors 110, heaters 112, and/or hematocrit sensors 118 may,in accordance with some embodiments, be embodied in one or more of acell resuspension tub, agitator device, and/or tubing system (not shown)of a cell resuspension system 100. In one example, based on a readingreceived from a temperature sensor 110, the processor(s) 104 may directa heater 112 to turn on or off, or to otherwise provide or ceaseproviding heat (e.g., to fluid in a tubing system). As also discussed inthis disclosure, one or more pumps 114 may, in accordance with someembodiments, be embodied in one or more of a cell resuspension tubsystem and/or tubing system of a cell resuspension system 100 (e.g., forcontrolling the transmission of fluid into and/or out of a cellresuspension tub). In one example, based on a signal from a fill sensor116 indicating that a cell resuspension tub has reached a predeterminedlevel, the processor(s) 104 may direct a pump 114 to stop pumping fluidand/or may direct a motor 120 to turn on and/or engage a drive shaft torotate or otherwise agitate the cell resuspension tub.

According to some embodiments, communication functions of a cellresuspension system may be facilitated through one or more wired and/orwireless communication subsystem(s) 122. According to some embodiments,cell resuspension information and/or patient information may be receivedfrom and/or transmitted to the processor(s) 104 via communicationsubsystem(s) 122. Communications may, in one or more embodiments, beassociated with a “network” or a “communication network”. As used inthis disclosure, the terms “network” and “communication network” may beused interchangeably and may refer to any object, entity, component,device, and/or any combination thereof that permits, facilitates, and/orotherwise contributes to or is associated with the transmission ofmessages, packets, signals, and/or other forms of information betweenand/or within one or more network devices. In some embodiments, networksmay be hard-wired, wireless, virtual, neural, and/or any otherconfiguration or type of network that is or becomes known. Networks maycomprise any number of computers and/or other types of devices incommunication with one another, directly or indirectly, via a wired orwireless medium such as the Internet, LAN, WAN or Ethernet (or IEEE802.3), Token Ring, RF, cable TV, satellite links, or via anyappropriate communications means or combination of communications means.In some embodiments, a network may include one or more wired and/orwireless networks operated in accordance with any communication standardor protocol that is or becomes known or practicable. Exemplary protocolsfor network communications include but are not limited to: the FastEthernet LAN transmission standard 802.3-2002® published by theInstitute of Electrical and Electronics Engineers (IEEE), Bluetooth™,Time Division Multiple Access (TDMA), Code Division Multiple Access(CDMA), Global System for Mobile communications (GSM), Enhanced Datarates for GSM Evolution (EDGE), General Packet Radio Service (GPRS),Wideband CDMA (WCDMA), Advanced Mobile Phone System (AMPS), Digital AMPS(D-AMPS), IEEE 802.11 (WI-FI), IEEE 802.3, SAP, the best of breed (BOB),system to system (S2S), or the like. Communication between and/or amongdevices may be encrypted to ensure privacy and/or prevent fraud in anyone or more of a variety of ways well known in the art. The specificdesign and embodiment of the communication subsystem 122 may depend onthe communication network(s) over which the cell resuspension system 100is intended to operate for a desired implementation.

Devices that are in communication with each other need not be incontinuous communication with each other, unless expressly specifiedotherwise. On the contrary, such devices need only transmit to eachother as necessary or desirable, and may actually refrain fromexchanging data most of the time. For example, a machine incommunication with another machine via the Internet may not transmitdata to the other machine for weeks at a time. In addition, devices thatare in communication with each other may communicate directly orindirectly through one or more intermediaries.

The I/O subsystem 140 may include operator panel controller 142 and/orother input controller(s) 144. The operator panel controller 142 may becoupled, for example, to an operator panel 146 (e.g., a touch screen, abutton panel). The operator panel 146 and operator panel controller 142may, for example, detect the actuation by a user of one or more hardwarebuttons and/or switches. A touch screen may, for example, also be usedto implement virtual or soft buttons and/or a keyboard. For example, theoperator panel 146 and operator panel controller 142 may, in a touchscreen embodiment, detect contact and movement or break thereof usingany of a plurality of touch sensitivity technologies, including but notlimited to capacitive, resistive, infrared, and surface acoustic wavetechnologies, as well as other proximity sensor arrays or other elementsfor determining one or more points of contact with the operator panel146. The user may be able, in some embodiments, to customize afunctionality of one or more buttons or other input means of theoperator panel 146.

The other input controller(s) 144 may be coupled to other input/controldevices 148, such as one or more buttons, rocker switches, thumb-wheel,infrared port, USB port, and/or a pointer device such as a mouse orstylus.

The memory interface 102 may be coupled to memory 150. The memory 150may include high-speed random access memory and/or non-volatile memory,such as one or more magnetic disk storage devices, one or more opticalstorage devices, and/or flash memory (e.g., NAND, NOR). The memory 150may store an operating system (not system), such as ANDROID, DARWIN,RTXC, LINUX, UNIX, OS X, WINDOWS.

The memory 150 may also store communication instructions 154 tofacilitate communicating with one or more additional devices, one ormore computers and/or one or more servers.

The memory 150 may include sensor processing instructions 172 tofacilitate sensor-related processing and functions and/or cellresuspension software instructions 174 to facilitate any one or more ofvarious other processes and functions for resuspending cells, adescribed in this disclosure.

Each of the above identified instructions and applications maycorrespond to a set of instructions for performing one or more functionsdescribed above. These instructions need not be implemented as separatesoftware programs, procedures, or modules. The memory 150 may includeadditional instructions or fewer instructions. Furthermore, variousfunctions of the cell resuspension system 100 may be implemented inhardware and/or in software, including in one or more signal processingand/or application specific integrated circuits.

As depicted in FIG. 1, cell resuspension system 100 may comprise a cellresuspension tub system 160, as discussed with respect to variousembodiments in this disclosure. Cell resuspension tub system 160 maycomprise one or more fluid systems 162 (e.g., an inlet tubing system, anoutput tubing system) and one or more cell resuspension tubs 164.Various examples of fluid systems and cell resuspension tubs arediscussed in this disclosure. As indicated in FIG. 1, in accordance withsome embodiments, cell resuspension tub 164 may be configured forconnecting with motor 120 and/or may be mechanically coupled to motor120. As depicted in FIG. 1, in some embodiments, one or more componentsof cell resuspension tub system 160 (e.g., inlet tubing, cellresuspension tub 164) may be connected to, may comprise, and/or may beconfigured to be received by one or more of the components incommunication with the controller interface 106. In one example, cellresuspension tub 164 may comprise one or more fill sensors 116configured to communicate with the processor(s) 104 via controllerinterface 106 (e.g., for indicating when the cell resuspension tub 164has been filled with fluid to a predetermined level). In anotherexample, a portion of inlet tubing of a fluid system 164 may be loadedthrough a heater 112.

FIG. 2 depicts a cross-section view of an example cell resuspension tubsystem 200 according to one or more embodiments. According to someembodiments, cell resuspension tub system 200 may comprise one or moreof the following components: a tub, a fin, a sensor (e.g., a fillsensor, a hematocrit sensor), a tub wall opening, a filter, a connector,a heat exchange element, tubing, a compressible segment, a tubing guide,a tubing connection, a clamp, an intravenous (IV) bag spike, and/or anIV bag.

According to some embodiments, soaking tub 202 comprises a vessel orcontainer with an opening at one end for receiving (e.g., from a user)one or more articles (e.g., surgical sponges and/or other types ofsurgical laundry) that include cells (e.g., blood cells) and/or fluids(e.g., blood). In one example, a user may place surgical sponges thatinclude blood and/or other bodily fluids collected during a surgical orother medical procedure (e.g., sponges that have been used to soak up orotherwise retain surgical blood) into the soaking tub 202. According tosome embodiments, soaking tub 202 is configured to be mounted in, on, orotherwise connected mechanically to an agitator device and/or a cellresuspension controller device. According to some embodiments, soakingtub 202 comprises a sterile tub or drum for only a single use.

According to some embodiments, soaking tub 202 comprises an open-endedcontainer or drum of metal or other rigid material. In one example,soaking tub 202 comprises a “U”-shaped vessel.

According to some embodiments, the soaking tub 202 may have an innerdiameter in the range of 15-21 inches (e.g., 18 inches) and/or a heightin the range of 12-18 inches (e.g., 15 inches). In one exampleembodiment, soaking tub 202 may have a volume capacity suitable forfilling with approximately 2684 ml of physiologic fluid (e.g., inaddition to one or more articles for soaking). It will readilyunderstood that any particular dimensions of the soaking tub may be usedas deemed desirable for a particular implementation (e.g., forparticular types and/or sizes of surgical articles).

In one or more embodiments, one or more inner and/or outer surfaces ofthe soaking tub 202 may comprise an anti-thrombotic surface, bio-passivesurface, and/or a bio-compatible surface configured to interact withblood for the purposes of reducing the inflammatory process oreliminating the possibility of thrombus formation and/or plateletadhesion. In some embodiments, a surface may be prepared by applying orcoating the surface with an anti-thrombotic substance (e.g., X coatingby Terumo, Inc.).

In some embodiments, soaking tub 202 comprises dual walls, such as aninner tub wall and an outer tub wall. In one embodiment, an innermost(medial) wall of the soaking tub 202 is circumferentially perforatedwith one or more openings 212. Accordingly, the inner tub wall may, insome embodiments, allow fluid and/or recovered cells to pass through thefenestrated wall via the openings 212, while retaining any surgicallaundry or other articles within the inner tub wall (e.g., when the tubis drained via the outlet tubing).

According to one example, openings 212 comprise, by way of example andwithout limitation, round holes ½ of an inch in diameter andapproximately ½ of an inch apart from one another. It will readilyunderstood that any number of holes and/or any one or more diameters maybe used as deemed desirable for a particular implementation (e.g., forparticular types and/or sizes of surgical articles). In one embodiment,openings 212 extend from the bottom of the soaking tub 202 up to within3 inches from the top the soaking tub. For example, there may be noopenings in the top one to two inches of soaking tub 202.

According to some embodiments, one or more blades or fins 210 may beconnected to one or more of the interior bottom and/or inner wall of thesoaking tub 202. When the soaking tub 202 is rotated (e.g., by a motor),the fins 210 may assist in agitating any fluid in the soaking tub 202,thereby acting on the fluid and/or surgical laundry in the tub to assistin liberating any cells collected in the surgical laundry. In oneexample, three uniform individual plastic “fins” project inward from theinnermost (medial) wall of the soaking tub 202. In another example, eachfin 210 measures 10-15 inches (e.g., 13 inches) from the bottom of thesoaking tub 202 towards the top and extending in toward the middle ofthe tub 2¾ inches. In one embodiment, the shape of a fin may beconfigured to facilitate removal of surgical laundry by hand. In oneexample, the fins may be tapered, rounded, or otherwise shaped and/orsized in order to accommodate the introduction of a user's hand into theinterior of the soaking tub 202 (e.g., without edges or protrusions thatmay cut or pierce a user's skin and/or gloves).

According to some embodiments, one or more of the fins 210 may comprisefenestrations, gaps, passages, or other types of openings in thestructure of the fin allowing at least some fluid in the soaking tub 202to pass through the fin (e.g., as the fin is agitating the fluid).Applicant has recognized that allowing for fluid to pass through a finmay beneficially eliminate splashing of the fluid and/or may preservesome of the rotational energy of the suspension fluid as it is rotating,which may more improve the efficiency of reclaiming cells from surgicallaundry. In an embodiment without such fenestrations, the potentialmotion of the fluid is more limited (e.g., to movement between or aroundtwo adjacent fins).

In one or more embodiments, the soaking tub 202 may comprise at leastone fill sensor 208 for detecting at least one of: presence of apredetermined level of fluid in the soaking tub 202 and/or a volume offluid in the soaking tub 202. In one embodiment, fill sensor 208comprises a sensor for detecting when a level of fluid reaches apredetermined height in the soaking tub 208. In one example, fill sensor208 is inside the outermost wall of the soaking tub 202. Overfilling ofthe soaking tub may cause contamination (e.g., of the cell resuspensiontub system, cell resuspension agitator device, and/or cell resuspensioncontroller device) and/or loss of any bloody suspension fluid thatspills out.

In one embodiment, fill sensor 208 may be configured so that when itcomes into contact with fluid or otherwise detects the presence of fluidat a predetermined level of the soaking tub 208 (e.g., a maximum fillheight), it sends a signal indicating it has detected fluid. In one ormore embodiments the fill sensor 208 may comprise a sensor configured todetect a ground fault caused when some medium (e.g., fluid reaching acertain level in the soaking tub) creates an electrical connectionbetween two points or nodes of the sensor.

For example, if soaking tub 202 is filled to the height of fill sensor208, the sensor detects the presence of fluid and transmits a signal toa controller device. In one example, the controller device may terminatea fill process in response to receiving a signal from the fill sensor208 (e.g., by stopping a roller pump or other type of pump device frompumping additional fluid into soaking tub 202). According to oneembodiment, the fill sensor 208 is configured to prevent the overfillingof fluid by triggering the deactivating (e.g., by a controller device)of an inlet side occlusive roller pump from engaging.

In one embodiment, the fill sensor 208 comprises a sensor fordetermining a volume status of the soaking tub 202 in accordance with avolume equation:

V=h×3.14×r ²,

in which h and r represent the height and inner radius, respectively, ofthe soaking tub 202.

In one or more embodiments, soaking tub 202 and/or y-type tubingconnection 222 may comprise one or more filters 214. Filter 214, inaccordance with some embodiments, may be configured to prevent debris,clots, articles from which cells are being reclaimed, and/or otherunwanted matter and materials, from exiting the soaking tub 202 and/orentering y-type tubing connection 222, inlet tubing 204, and/or outlettubing 206. According to one or more embodiments, filter 214 isconfigured to allow resuspended cells (e.g., red blood cells) to passout of the soaking tub 202, while retaining unwanted materials in thesoaking tub 202.

In one example, red blood cells, suspended or otherwise carried alongwith physiologic fluid used to extract the red blood cells from bloodysurgical articles, may pass through the filter at the bottom of soakingtub 202, into y-type tubing connection 222, and into outlet tubing 206,while the surgical articles remain in the soaking tub 202. According tosome embodiments, filter 214 similarly may prevent (e.g., during a tubfilling process) unwanted matter from entering soaking tub 214 via theinlet tubing 204 and/or y-type tubing connection 222.

In some embodiments, cell resuspension tub system 200 may comprise aconnector for removably fixing, mounting, or otherwise connecting thesoaking tub 202 to a drive source (e.g., a motor) for rotating thesoaking tub 202. In one or more embodiments, a connector is attached tothe underside of a soaking tub and is configured to be removablyinserted or otherwise connected to a corresponding rotatable connector(e.g., a connecting end of a motor's drive shaft). When the connectorsare connected and rotating, the soaking tub 202 is caused to rotate.

In some embodiments, a male connector 220 is attached to the undersideof soaking tub 202 and is configured to be removably inserted orotherwise connected to a corresponding rotatable female connector (e.g.,of an agitator device) for rotating the soaking tub 202. In one example,the male connector 220 comprises a multifaceted block of metal or otherrigid material affixed to the soaking tub in a manner such that when themale connector 220 is rotated, it rotates the soaking tub 220. Accordingto the example, the male connector is of a multifaceted shape designedto fit into a corresponding female connector for receiving and rotatingthe male connector 220.

Some examples of connector designs for removably securing and rotatingthe soaking tub 202 are discussed in this disclosure; various other waysof shaping and designing respective connectors to be rotatably connectedto one another will be readily understood by those skilled in the art inlight of the present disclosure.

According to some embodiments, male connector 220 comprises or may becoupled with y-type tubing connection 222. In one embodiment, maleconnector 220 may comprise: (i) one or more holes or channels allowingfluid to pass in and/or out of soaking tub 202 via y-type tubingconnection 222, (ii) one or more holes or channels allowing fluid topass into soaking tub 202 via inlet tubing 204, and/or (iii) one or moreholes or channels allowing fluid to pass out of soaking tub 202 viaoutlet tubing 206.

According to some embodiments, inlet tubing 204 and/or outlet tubing 206may comprise one or more coils. In some embodiments, coils of tubing 204and/or 206 may be placed inside a controller device (e.g., an integratedcell resuspension appliance) with the soaking tub 202 and/or othercomponents of a cell resuspension tub system 200.

Inlet tubing 204 and/or outlet tubing 206 may comprise polyvinylchloride (PVC) tubing. In one or more embodiments, one or more innerand/or outer surfaces of the soaking tub 202 may comprise ananti-thrombotic surface, bio-passive surface, and/or a bio-compatiblesurface. In one embodiment, the inlet tubing 204 is 40 inches in lengthwith a 3/16-inch inner diameter. In some embodiments, tubing maycomprise one or more rigid plastic sleeves or other type of “tubing bendrelief” for preventing kinking of the tubing. In various embodiments,tubing may comprise at least one sterile cap on an end of the tubing(e.g., to maintain sterility of the interior of the tubing prior touse).

In one embodiment, inlet tubing 204 may comprise at least one heatexchange segment 226 comprising a material suitable for conductivetransfer of heat. For example, the heat exchange segment 226 maycomprise stainless steel and/or other types of conductive metal.According to one example, the heat exchange segment 226 comprisesstainless steel tubing (e.g., up to approximately 6 inches in length).In another example, the heat exchange segment 226 is not made of PVC orplastic. It will be readily understood that any length and/or materialfor a heat exchange element may be used as deemed desirable for aparticular implementation.

In one or more embodiments, the location of the heat exchange segment226 along inlet tubing 204 is configured to allow the heat exchangesegment 226 to be inserted into or otherwise be in contact with aheating element and/or other heat exchange surface (e.g., integrated ina cell resuspension controller device and/or controlled by a cellresuspension controller device).

In one embodiment, inlet tubing 204, outlet tubing 206, and/or soakingtub 202 may comprise one or more heating elements for heating fluid(s).

According to some embodiments, inlet tubing 204 may comprise at leastone compressible segment 230 comprising a material suited for mechanicalcompression and/or manipulation of the tubing segment. In oneembodiment, compressible segment 230 comprises a compressible silasticmaterial.

In one or more embodiments, compressible segment 230 may be manipulatedby a roller pump or other pump device in order to force fluid throughthe inlet tubing 204 (e.g., into soaking tub 202 and/or out throughoutlet tubing 206).

In one embodiment, compressible segment 230 may be configured, by thematerial used and/or by its placement along inlet tubing 204, to beloaded into a roller pump and/or raceway (e.g., of an agitator device orcontroller device).

According to one example, compressible segment 230 comprises a segmentof compressible silastic material approximately 9 inches in length, thatmay be loaded through a dual head roller pump and raceway integrated inan agitator device.

According to some embodiments, inlet tubing 204 and/or outlet tubing 206may comprise one or more tubing guides or plugs, such as tubing guides228 and 231, configured to ensure that the tubing is installedcorrectly. For example, in accordance with one or more of variousembodiments discussed in this disclosure, tubing may be held in placeby, connected to, and/or affixed to an agitator device, controllerdevice, pump device, and/or other type of device or apparatus. Mosttubing is uniform in nature, allowing for the possibility that it may beinadvertently loaded incorrectly (and/or unsafely) in the wrongdirection. Applicants have recognized that it may be advantageous, inaccordance with some embodiments described in this disclosure, toprovide for one or more specifically shaped guides that only line upwith their respective and correspondingly shaped indents, sockets, orreceptacles, to prevent loading the tubing in the wrong direction and/oran inappropriate pathway (e.g., a round protuberance will only line upwith an inlet side of a tubing raceway and a square protuberance willonly line up with an outlet side of the raceway).

In one or more embodiments, a tubing guide comprises a protuberanceattached to the tubing. In one example, a tubing guide may comprise acube, rectangular prism, cylinder, sphere, or other shaped guide, and atleast a portion of the tubing passes through and/or is affixed to theguide. In some embodiments, tubing guides 228 and 231 may comprisespecific shapes only to be inserted into their shape specificcounterparts for a desired tubing path and/or direction (e.g., as tubingpathway guides and/or raceway direction guides).

According to some embodiments, the shape of a tubing guide is configuredto be removably inserted into a correspondingly shaped socket,receptacle or depression. When the tubing guide is inserted in theappropriately-shaped socket (e.g., a cylindrical or spherical guide intoa round hole), the guide holds the tubing in place (e.g., in a rollerpump assembly).

According to some embodiments, one or more tubing guides may be used toeliminate the possibility of inadvertently connecting or loading tubingin the wrong direction.

In one example, the proximal side of the compressible segment 230 ofinlet tubing 204 may pass through or otherwise be attached to a roundprotuberance (e.g., ½ inch diameter), and the distal side of thecompressible segment 230 may pass through or otherwise be attached to asquare protuberance (e.g., ½ inch square). The round protuberance is forinsertion into a first corresponding socket to ensure, for example, thatthe inlet tubing is oriented properly to bring fluid (e.g., from an IVbag attached to that end of the inlet tubing) into a roller pumpassembly.

It will be readily understood that although two insert guides aredepicted in FIG. 2, a tubing guide comprising an asymmetrical design, incombination with a corresponding receptacle design, may be sufficientfor ensuring that tubing is oriented correctly (e.g., that inlet oroutlet tubing is not loaded in the wrong direction), if inserting theasymmetrical guide ensures that the tubing can only be oriented in onedirection. Any number and/or design of insert guides may be appropriate,as deemed desirable for a particular implementation.

In one or more embodiments, the inlet tubing 204 and outlet tubing 206may be joined by a y-type tubing connection 222, such as a ThermoScientific™ Nalgene® y-type polypropylene tubing connector or wyeconnector by Teleflex. In one embodiment, at least one end of y-typetubing connection 222 passes through male connector 220, allowing forfluid to flow in and/or out of soaking tub 202. Y-type tubing connection222 may be useful, in accordance with some embodiments, to facilitate(1) filling the soaking tub with physiologic solution (not shown) and/or(2) emptying the soaking tub of the bloody suspension fluid (not shown).

According to some embodiments, inlet tubing 204 comprises one or moreintravenous (IV) bag spikes 236 for supplying one or more types of fluid(e.g., physiologic fluid) to a cell resuspension tub system via inlettubing 204. Applicant has recognized that, in accordance with one ormore embodiments, soaking surgical laundry with physiologic suspensionsolution causes the dilution of the coagulation components of wholeblood, making clotting of the blood in the surgical laundry and/or acell saver less likely and yielding more salvageable blood from thecollection process. According to some embodiments, a cell resuspensionor reclamation process may comprise a step of soaking bloody surgicalsponges in a suspension fluid to allow the surgical laundry to becomesaturated with suspension fluid, further liberating blood from the wovencotton fibers of the sponges. According to one or more embodiments, aclinician may add other medicines, solutions, agents, and/or infusibleproducts (e.g., in addition to physiologic solution) to the soaking tub(e.g., at a pre-determined ratio). It may be advantageous, in accordancewith some embodiments, to use one or more additional products to enhancethe yield of the bloody suspension fluid from surgical laundry and/or toadd one or more agents to the suspension fluid to make re-infusion ofthat fluid better for the patient and/or to increase the viability ofrecovered cells. Diluting the blood with a physiologic solution or otheragent may inhibit the enzymatic reactions that are necessary forcoagulation to occur. In one example, the use of blood collection agentsadded or mixed with the physiologic solution such ascitrate-phosphate-dextrose (CPD-A1 or A2) may aide in the viability,anticoagulation, nourishment, and suspension of any sponge bloodreclaimed during a soak/rinse process.

In one or more embodiments, inlet tubing 204 may comprise one or moreclamps 234 (e.g., Roberts clamps) for starting, stopping, adjusting, orotherwise controlling the release of fluids (e.g., physiologic solution)into the inlet tubing 204 (e.g., from one or more IV bags).

According to some embodiments, inlet tubing 204 may comprise a y-typespike connection 232, allowing two or more IV bags (not shown) to beattached to the inlet tubing (e.g., via IV bag spikes 236).

As depicted in FIG. 2, inlet tubing 204, clamps 234, and y-type spikeconnection 232 may allow for multiple products to be introducedindividually into a single tubing line and/or to be combined (e.g., in apredetermined ratio) into a common tubing line that may be run throughone or more types of pumps, heaters, and/or sensors. In accordance withsome embodiments, one or more additional tubing lines may be utilized.In one or more embodiments, multiple tubing lines may be run through oneor more of any pumps, heaters, sensors, and/or other components. In someembodiment, inlet tubing 204 may be configured to include a first tubingline having its own respective one or more IV spikes and/or spikeconnections for introducing products into the first tubing line, and mayfurther include a second tubing line having its own respective one ormore IV spikes and/or spike connections for introducing products intothe second tubing line. In some embodiments, the separate first andsecond tubing lines may be run through the same one or more componentsand/or the first tubing line may be run through one or more componentsthat the second tubing line is not run through. In some embodiments, thefirst and second tubing lines may join together (e.g., via a tubingconnection) after at least one of the tubing lines has been run throughone or more components.

According to one hypothetical example, a first tubing line forintroducing physiologic fluid and a separate, second tubing line forintroducing a drug (e.g., heparin) both may be run through the sameroller pump assembly (e.g., roller pump assembly 909) and then connecttogether into a common tubing line after passing through the roller pumpassembly. The amount of fluid and/or amount of the drug being introducedmay be individually controlled (and/or a desired ratio achieved) basedon, for example, the respective diameter of the corresponding tubingline (e.g., 3/16-¼ inch for the physiologic solution tubing, ⅛ inch forthe drug tubing). In another example, a first and second tubing line mayconnect together after the first tubing line has passed through a rollerpump assembly and after the second tubing line has passed separatelythrough the same or a different roller pump assembly and also through aheater. In another example, a first and a second tubing line may connecttogether after both have passed separately through two or morecomponents. In another example, a first and a second tubing line mayconnect together after the first tubing line has passed through at leastone component and before the second tubing line passes through anycomponent. In one embodiment, one or more separate tubing lines do notconnect (e.g., each is pumped and empties separately into a soakingtub). Various configurations of one or more tubing lines, components,and/or connections, suitable for desirable implementations, will bereadily understood those skilled in the art in light of this disclosure.

As discussed in this disclosure, outlet tubing 206 may be loaded throughone or more of: an occlusive clamp, a flow sensor, and/or an airdetector (e.g., mounted on an agitator device or controller device). Inone embodiment, the outlet tubing 206 has a 3/16-inch inner diameter.

In one or more embodiments, outlet tubing 206 may comprise a portion 270for loading through a flow sensor and/or air detector (e.g., a combinedflow/air detector). According to some embodiments, outlet tubing 206 maycomprise at least one type of sensor for measuring an amount of cells(e.g., red blood cells) in a fluid. In one embodiment, outlet tubing 206may comprise a hematocrit sensor 224 (e.g., an In-Line hematocrit sensorby In-Line Diagnostics Corporation) for measuring a volume of recoveredred blood cells suspended in a physiologic solution (e.g., red bloodcells extracted from surgical sponges in soaking tub 202).

According to some embodiments, soaking tub 202 and/or one or more othercomponents of cell resuspension tub system 200 may comprise one or moresterile components. For example, soaking tub 202, inlet tubing 204,and/or outlet tubing 206 may be sterilized and/or packaged in a sterilemanner appropriate for medical use (e.g., for introduction to and use ona sterile field; during a surgical or other medical procedure).

According to some embodiments, soaking tub 202 and/or one or more othercomponents of cell resuspension tub system 200 are for a single use. Forexample, cell resuspension tub system 200 may be used during only asingle surgical procedure, for only a single patient, for extractingcells from only a single set of one or more surgical articles, and/orfor only one cell resuspension process.

FIG. 3 depicts a cross-section view of an example cell resuspensionsystem 300 according to one or more embodiments. As shown in FIG. 3, theexample cell resuspension system 300 comprises a soaking tub 202mechanically coupled with a cell resuspension agitator device 302. Inparticular, in accordance with some embodiments, a connector 220 of thesoaking tub 202 comprises a portion 304 for removably mounting orotherwise coupling the soaking tub 202 to the connector 306 of the cellresuspension agitator device 302.

In one example, as shown in FIG. 3, the connector 306 comprises a femaleconnector (e.g., comprising or attached to a drive mechanism forrotating soaking tub 202) configured for receiving portion 304, which isconfigured to fit into the connector 306.

According to some embodiments, connector 306 comprises, is coupled to,or is integrated into a motor assembly comprising a motor for rotatingthe soaking tub 202.

As shown in FIG. 3, the example cell resuspension system 300 maycomprise fluid input means 308 (e.g., inlet tubing 204) for introducingfluid into the soaking tub 202 and/or fluid output means 310 (e.g.,outlet tubing 206) for removing fluid (e.g., fluid including suspendedcells) from the soaking tub 202. In one embodiment, outlet tubing 206may be connected to a cell saver and/or a cardiopulmonary machine.

According to some embodiments, a controller device, agitator device,and/or cell resuspension tub system may comprise one or more temperaturethermistors for measuring a temperature of fluid in one or more of afluid intake system, fluid output system, and/or soaking tub.

FIG. 4 depicts a top view of an example cell resuspension system 400comprising a soaking tub 202 rotatably mounted in a cell resuspensionagitator device 302, in accordance with one or more embodiments. Asshown in FIG. 4, the cell resuspension agitator device 302 may beconfigured (e.g., using a rotating drive shaft coupled to the soakingtub 202) to rotate soaking tub 202 clockwise and/or counterclockwise. Insome embodiments, cell resuspension system 400 is configured to rotatesoaking tub 202 clockwise and counterclockwise through a limited rangeof rotation (e.g., 270 degrees, 90 degrees, 2.5 rotations, 1080degrees). According to some embodiments a length of slack tubing (e.g.,configured as one or more tubing coils) in fluid input means 308 and/orfluid output means 310 may be configured to accommodate a desired rangeof rotation of the soaking tub 202.

As depicted in FIG. 4, soaking tub 202 may comprise one or more fins 210for agitating the fluid 404 when the soaking tub 202 is rotated.According to some embodiments, the back and forth rotation causes thefins 210 to agitate the fluid 404 and/or the articles 402. In oneexample, the rotation of the soaking tub 202 by the cell resuspensionagitator device 302 provides friction, turbulence, and/or mechanicalaction to the fluid 404 and/or articles 402 to remove cells (e.g., redblood cells) from the articles 402. According to one embodiment, anycells freed from the articles 402 may be suspended in the fluid 404(e.g., for removal with the fluid 404 through outlet tubing 310).

FIG. 5 depicts a top view of an example cell resuspension agitatordevice 500 according to one or more embodiments. The cell resuspensionagitator device 500 may, in some embodiments, be configured forcombination with a cell resuspension tub and/or cell resuspension tubsystem (indicated by dashed lines in FIG. 5). As shown in FIG. 5, cellresuspension agitator device 500 may comprise walled cabinet 504 (e.g.,constructed of a rigid material such as, without limitation, aluminum,plastic, or stainless steel) or frame for housing, containing, and/orintegrating one or more components of the agitator device. In someembodiments, embodiment cell resuspension agitator device 500 maycomprise a lid and/or a bottom portion or panel (not shown). In oneembodiment, cell resuspension agitator device 500 may comprise a drainfor draining the agitator device should it be contaminated with spillage(e.g., from a cell resuspension tub).

As depicted in FIG. 5, cell resuspension agitator device 500 maycomprise an agitating drive assembly 506 for providing rotating or othertype of agitating motion to a cell resuspension tub (e.g., to producefriction and/or turbulent motion for freeing cells from surgicalarticles). In some embodiments, agitating drive assembly 506 maycomprise or be coupled to a power source (not shown), such as a motorand/or drive shaft, for rotating a cell resuspension tub. In oneembodiment, cell resuspension agitator device 500 comprises an agitatingdrive assembly 506 but does not comprise a cabinet, frame, or walls.

In accordance with some embodiments, as discussed in this disclosure,agitating drive assembly 506 may be or may comprise a male, female, orother type of connector for coupling with a corresponding connector of acell resuspension tub. For example, agitating drive assembly 506 maycomprise a female connector (e.g., connector 306 (FIG. 3)) for rotatablycoupling with male connector 220 of cell resuspension tub 202, as shownin FIG. 2. Although shown as having a multifaceted, hexagonal shape, itwill be readily understood that agitating drive assembly 506 may beconfigured in any shape suitable for securely and rotatably connectingwith a correspondingly shaped connector of a cell resuspension tub.

In some embodiments, agitating drive assembly 506 may comprise a groove,passageway, or other type of channel 502 for allowing the tubing orother means for conducting fluid (e.g., inlet tubing 204 (FIG. 2)) topass through one or more sides of the agitating drive assembly 506 whena soaking tub receiving such tubing (e.g., via a y-type tubingconnection) is mounted in agitating drive assembly 506.

FIG. 6 depicts a top view of an example cell resuspension agitatordevice 600 according to one or more embodiments. Similar to the cellresuspension agitator device described with respect to FIG. 5, the cellresuspension agitator device 600 may, in some embodiments, be configuredfor combination with a cell resuspension tub and/or cell resuspensiontub system (indicated by dashed lines in FIG. 6). Cell resuspensionagitator device 600 may comprise an agitating drive assembly 606 forproviding rotating or other type of agitating motion to a cellresuspension tub. In some embodiments, agitating drive assembly 506 maycomprise or be coupled to a power source (not shown).

As shown in FIG. 6, in accordance with some embodiments, agitating driveassembly 506 comprise a male, female, or other type of connectorcomprising one or more fins, blades, or other rotation securing element608 protruding from an interior side of the agitating drive assembly forcoupling with a corresponding connector of a cell resuspension tub. Forexample, the rotation securing element(s) 608 may fit into correspondingreceptacles, slots, sockets, or the like, in the cell resuspension tubwhen the tub is properly mounted. Accordingly, the rotation securingelement 608 may help to secure the cell resuspension tub to agitatingdrive assembly 506 and/or provide rotational motion to the cellresuspension tub when the agitating drive assembly 606 is rotating.Although shown as having a generally circular shape, it will be readilyunderstood that agitating drive assembly 606 may be configured in anyshape, and/or with any number and/or shape of rotation securing elements608, suitable for securely and rotatably connecting with acorrespondingly shaped connector of a cell resuspension tub.

In some embodiments, agitating drive assembly 606 may comprise one ormore channels 602, for allowing the tubing or other means for conductingfluid to pass into a mounted soaking tub. According to some embodiments,as shown in FIG. 6, cell resuspension agitator device 600 may alsocomprise a cabinet 604.

According to some embodiments, an agitating drive assembly may beconfigured to couple magnetically and/or electromagnetically (e.g., witha corresponding cell resuspension tub connector) in order to provide fora secure connection. In one embodiment, a magnetized female connectormay be utilized to hold securely a corresponding male connector of asoaking tub, without necessarily requiring the male connector be of amultifaceted design or requiring connecting fins, blades, or the like,in order for the female connector to rotate the soaking tub.

FIG. 7 depicts a perspective view of an example cell resuspension system700 according to one or more embodiments. Cell resuspension system 700may comprise, in accordance with some embodiments: a lid 704, a cellresuspension tub 705, a user control panel 710, a cell resuspensioncontroller device 711, fluid intake system 712, and fluid output system714.

The lid 704, for example, may comprise a lid hinged to the top of a sideof the cell resuspension controller device 711 (e.g., hinged to the topof the back panel). In some embodiments, the lid 704 may be constructedof plastic and/or glass. The lid 704 may be clear, in accordance withone or more embodiments, to allow a user to see into the interior of thecell resuspension controller device 711 and/or cell resuspension tub705. As shown in FIG. 7, the lid 704 may comprise one or more notches orgrooves to allow passage of tubing or other means for providing fluid inand/or out of the cell resuspension controller device 711 and/or cellresuspension tub 705.

In one embodiment, the underside of lid 704 may comprise a cover or lidconfigured to cover the top opening of cell resuspension tub 705 toprevent spilling or splashing fluid from the tub (e.g., during afilling, draining, and/or agitating process). In one example, a cover ofa shape and size suitable for sealing or closing the opening at the topof the cell resuspension tub 705 may be affixed to or integrated withthe underside of lid 704. According to various embodiments, theunderside of a cover for sealing the tub opening against fluid spillagemay be concave, convex, or flat. In one embodiment, a cover having anunderside with a convex surface extending into the tub (e.g., coming toa downward point or a spherical surface bowing into the tub) mayadvantageously allow any spilled or splashed fluid accumulating on theunderside of the cover to drain, in accordance with the gravitationalpull, toward the center of the cover. Alternatively, a tub system maycomprise a covering for a tub that is not attached to lid 704 (or isremovably attachable to lid 704).

As shown in a close-up detail in FIG. 7, in some embodiments a sleeve706 may be used with the lid 704. For example, a sterile, single-use,plastic sleeve having an opening on at least one end, may be placed by auser around the lid 704 prior to initiating a cell resuspension process.In some embodiments, one or more protective coverings or sheets, ratherthan a single sleeve, may be used to cover the top and/or underside ofthe lid 704. In one embodiment, the sleeve 706 is transparent or clearenough to allow a user to view the interior of the cell resuspensioncontroller device 711 and/or the cell resuspension tub 705 through thelid 704.

As shown in FIG. 7, the user control panel 710 may comprise, in someembodiments, one or more displays, touchscreens, buttons, switches,keypads, or the like, and/or any combination of desirable input and/oroutput devices deemed desirable for initiating, monitoring, modifying,controlling, and/or receiving information about a cell resuspensionprocess. Various types of functions that may be provided by a cellresuspension controller device are described in this disclosure, and oneor more of such functions may be provided via the user control panel710.

As shown in a close-up detail in FIG. 7, in some embodiments a usercontrol panel covering 708 (e.g., a sheet of plastic) may be used toprotect and/or keep sterile the user control panel 710. In oneembodiment, as depicted in FIG. 7, the user control panel covering 708may be removably affixed (e.g., using an appropriate adhesive) at leastat portion 709 (e.g., an adhesive strip along the top of the usercontrol panel covering 708) to the user control panel 710. According tosome embodiments, the user control panel covering 708 may be for asingle use and may be replaced by a user for each use of the cellresuspension controller device 711.

The cell resuspension controller device 711 may comprise, as shown inFIG. 7, an outer cabinet with lid 704 and user control panel 710. Insome embodiments, the cell resuspension controller device 711 maycomprise one or more of: a processor, a computer readable memory (e.g.,storing computer readable instructions for directing the processor toperform a cell resuspension process), one or more input devices, one ormore output devices, a power supply, a connecting drive assembly (e.g.,for coupling with and rotating the cell resuspension tub 705), a motor,and/or a communication port. Cell resuspension controller device 711 maycomprise and/or be in communication with, according to some embodiments,a cell resuspension agitator device 500 for coupling with and rotating asoaking tub (e.g., soaking tub 202 of cell resuspension tub system 200).

According to some embodiments, the cell resuspension controller devicemay be configured (e.g., in accordance with one or more hardware and/orsoftware controllers) to provide for one or more of the followingfunctions:

-   -   a. monitoring and/or controlling input of physiologic fluid to a        soaking tub and/or cell resuspension tub system    -   b. monitoring and/or controlling one or more roller pump or        other types of pump devices for controlling the filling and/or        emptying of a soaking tub and/or cell resuspension tub system    -   c. monitoring and/or controlling one or more clamping valves to        facilitate the filling of a soaking tub with a physiologic        solution    -   d. monitoring and/or controlling one or more clamping valves to        facilitate the emptying of a soaking tub of physiologic solution        (e.g., bloody physiologic suspension solution)    -   e. monitoring and/or controlling a temperature of a fluid (e.g.,        a physiologic solution)    -   f. monitoring and/or controlling one or more heat exchange        surfaces (e.g., for controlling temperature)    -   g. controlling the motion of a multifaceted receiver to provide        for turbulence and/or rotational motion in a soaking tub (e.g.,        rotating a fluid filled tub back and forth through a 180-240        degree range to create turbulence in the fluid)    -   h. spinning and/or rotating a soaking tub    -   i. controlling the operation of a lid and/or latch (e.g.,        allowing/securing access to an interior of an agitator device        for installing and/or removing a soaking tub and/or cell        resuspension tub system)    -   j. tracking, monitoring, storing (e.g., for documentation to a        patient's medical record), and/or transmitting information        related to one or more of:        -   volume of blood loss (e.g., as collected from sponges)        -   volume of physiologic solution fluid in (e.g., to a soaking            tub)        -   volume of (bloody) suspension fluid out (e.g., from a            soaking tub)        -   a hematocrit measure of the suspension fluid

The cell resuspension tub 705, as discussed with respect to variousembodiments in this disclosure, may comprise a soaking tub, connectorfor connecting the soaking tub to a cell resuspension agitator device, afilter, tubing, and/or one or more tubing connectors. For example, cellresuspension tub 705 may comprise soaking tub 202, male connector 220,filter 214, and y-type tubing connection 222. In some embodiments, cellresuspension tub 705 may be manufactured and/or sold as part of a cellresuspension tub system. For example, cell resuspension tub 705 may beprovided as a sterile, single-use soaking tub with fluid intake system712 (e.g., inlet tubing 204) and/or fluid output system 714 (e.g.,outlet tubing 206), as part of a single-use cell resuspension tubsystem, for use with cell resuspension controller device 711.

According to some embodiments, fluid intake system 712 may comprise oneor more of the following: physiologic fluid, tubing, a tubing connector,a clamp, an IV bag spike, an IV bag, a compressible tubing segment, apump, a heat exchange element, and/or a heating element. According toone example, the fluid intake system 712 of FIG. 7 may comprise one ormore of the following example components discussed with respect to theexample cell resuspension tub system 200 of FIG. 2: inlet tubing 204,heat exchange element 226, tubing guides 228 and 231, compressiblesegment 230, IV bag spikes 236, clamps 234, and/or y-type spikeconnection 232.

According to some embodiments, fluid output system 714 may comprise oneor more of the following: physiologic fluid, tubing, a tubing connector,a clamp, a compressible tubing segment, a pump, a heat exchange element,a heating element, a hematocrit sensor, and/or a cell saver. Accordingto one example, the fluid output system 714 of FIG. 7 may comprise oneor more of the following example components discussed with respect tothe example cell resuspension tub system 200 of FIG. 2: outlet tubing206 and/or heat exchange element 226.

FIG. 8 depicts a front view of the example cell resuspension system 700according to one or more embodiments. As shown in FIG. 8, the examplecell resuspension system 700 may comprise: cell resuspension controllerdevice 711, including lid 704 and user control panel 710. As depicted,lid 704 may be closed, while the configuration of lid 704 (e.g., usingnotches or other passageways for tubing) may still allow fluid intakesystem 712 to provide fluid into the interior of cell resuspensioncontroller device 711 (e.g., into a mounted soaking tub (not shown)) andmay still allow fluid to exit via fluid output system 714. It will bereadily understood by one skilled in the art, in light of thisdisclosure, that the placement of various components described in FIG. 8may vary from what is depicted (e.g., the user control panel may be onan upper side of the cell resuspension controller device 711 and/orintegrated into lid 704).

FIG. 9 depicts an example side view of the example cell resuspensionsystem 700 according to one or more embodiments. In particular, FIG. 9depicts example components of an example fluid intake system forproviding fluid to the cell resuspension system (e.g., into a soakingtub (not shown)) for use in resuspending cells that were collected insurgical articles (e.g., bloody surgical sponges). According to someembodiments, fluid intake components may comprise one or more of thefollowing: IV bags 902, IV bag hooks 903 (e.g., for holding IV bags902), IV bag spikes 936 (e.g., for receiving fluid from IV bags 902),clamps 934 (e.g., for controlling flow of fluid from IV bags 902),y-type spike connection 932, tubing 904 (e.g., PVC tubing), roller pumpassembly 909 and roller pump 908, tubing guides 906 and/or 910 (e.g.,for ensuring that the tubing is loaded in the correct direction into theroller pump assembly 909), compressible segment 930, heat exchangesegment 926, and/or heating element 912.

Various types of pumps, including roller pumps and/or various positivedisplacement pumps, suitable for conducting fluid through tubing areknown to those skilled in the art. As depicted in FIG. 9, according tosome embodiments, at least a portion of tubing 904 may be loaded into aroller pump assembly 909 for pumping fluid (e.g., from IV bag 902) into,for example, a soaking tub (not shown) of the cell resuspension system700. In one example, a compressible segment 930 of tubing may be loadedinto a channel or “raceway” (e.g., a metallic raceway) of the rollerpump assembly 909 and around the roller pump 908. In one example, theroller pump 908 comprises an occlusive, dual headed roller pump havingtwo heads in opposition to one another. When the roller pump assembly909 is activated (e.g., via the user control panel 710), the roller pump908 rotates, acting on the compressible segment 930 and forcing fluidaway from a fluid source (e.g., IV bag 902). Alternatively or inaddition, one or more other pumps (e.g., roller pumps) may be used toadvance fluid into and/or out of a cell resuspension tub or tub system.According to some embodiments, a controller device and/or sensor maydetermine an amount of fluid added to a cell resuspension tub and/orsystem (e.g., from IV bags) based on a determination of an amount offluid passing through the raceway. In one example, the amount of fluidpassing through the raceway (e.g., per stroke of the raceway) may bedetermined based on an inner diameter of the tubing.

In one embodiment, the roller pump assembly 909 may be provided with orattached to tubing 904, and may be configured to plug into a socket orother receptacle by which it may be powered and/or controlled by cellresuspension controller device 711. In another embodiment, the rollerpump assembly 909 may have a power source and/or controller not providedby cell resuspension controller device 711. For example, the tubing 904may be coupled to a stand-alone pump device (e.g., with its own controlsand/or user control interface).

As shown in FIG. 9, an example fluid intake system 712 of the examplecell resuspension system 700 may also comprise one or more tubing guides906 and/or 910. Each of the tubing guides 906 and 910 may fit into arespective, correspondingly shaped socket (e.g., of the roller pumpassembly 909) such that a user is required to load the tubing 904 in thecorrect direction through the roller pump assembly 909.

Applicant has recognized that the temperature and viability of any bloodmay decrease significantly over time once it is outside the body and/orif allowed to equilibrate with the environmental temperature (e.g. of anoperating room). As the temperature of red blood cells decreases, sodoes the ability of the red blood cells to transfer oxygen. Accordingly,in some embodiments, a cell resuspension system may provide for heatingand/or maintaining a desired temperature of resuspended cells, which mayimprove the viability of red blood cells and their ability to transferoxygen, thereby improving the quality of the recovered blood forpurposes of autotransfusion, if desired.

The example cell resuspension system 700, according to some embodiments,may comprise one or more heating elements 912 and/or one or more heatexchange elements 926, to heat fluid in a fluid intake system, soakingtub, and/or fluid output system. In one example, heating element 912 maycomprise a heater such as an electric conductive heat exchanger. In oneembodiment, as depicted in FIG. 9, heat exchange element 926 may be aportion of tubing 904 configured to fit into a corresponding channel in(or otherwise be coupled with) heating element 912. In one embodiment,the heating element 912 may be provided with or attached to tubing 904,and may be configured to plug into a socket or other receptacle by whichit may be powered and/or controlled by cell resuspension controllerdevice 711. In another embodiment, the heating element 912 may have apower source and/or controller not provided by cell resuspensioncontroller device 711. For example, the tubing 904 may be coupled to astand-alone heating element (e.g., with its own user interface forsetting desired temperature). Although depicted in FIG. 9 as part of afluid intake path, alternatively or in addition, one or more heatingelements may be used in accordance with some embodiments to heat fluidin a cell resuspension tub and/or traveling through a fluid outputsystem. In one embodiment, a heating element may be embodied in a cellresuspension tub. For example, a heating element (e.g., electric wires)may be placed between the inner and the outer walls of a soaking tub forwarming the suspension fluid. In one embodiment, such wiring may travel(e.g., along with wiring for the fill sensor or other electricalcomponents) and exit the tub (e.g., at the bottom connector).

The example cell resuspension system 700, according to some embodiments,may further comprise the user control panel 710 and/or power connection914 (e.g., a power cord) for providing electrical power to one or morecomponents of the cell resuspension system 700. According to oneembodiment, the cell resuspension system 700 may comprise an electricalpower source (e.g., a battery, a generator).

As discussed with respect to one or more embodiments in this disclosure,a cell resuspension system may provide for collecting cells (e.g., redblood cells) from surgical articles (e.g., surgical sponges) using fluidand a rotating soaking tub. After a desired period of time and/or aftera desired amount of cells have been recovered, the fluid, now includingthe suspended cells, may be removed from the soaking tub via a fluidoutput system. In some embodiments, a pump (e.g., a roller pump) may beused to draw or force the fluid out of the soaking tub. In someembodiments, a fluid output system may conduct the collected cells, inthe fluid, to a cell saver and/or may comprise a cell saver or otherdevice for removing cells borne by the fluid.

Although FIG. 9 depicts an example fluid intake system configured tointroduce one or more products (e.g., fluids, agents) through variouscomponents using a single, common line of tubing, it will be readilyunderstood (as discussed with respect to FIG. 2) that two or moreseparate tubing lines (e.g., each with a respective one or more IV bagspikes) may be utilized and/or may connect to one another in variousways, as deemed desirable for a particular implementation.

FIG. 10 depicts another example side view of the example cellresuspension system 700 according to one or more embodiments. As shownin FIG. 10, the cell resuspension system 700 may comprise the cellresuspension controller device 711 (including the lid 704 and usercontrol panel 710) and a fluid output system 714. According to someembodiments, the fluid output system 714 may comprise one or more of:tubing 1012 (e.g. PVC tubing), a flow/air detector 1002, and/or ahematocrit sensor 1004. As indicated by the directional arrow, fluidpasses out of the cell resuspension controller device via tubing 1012.In one embodiment, the fluid may pass through a flow/air detector 1002,such as a flow/air detector by Transonic Corporation, providing for botha volume measurement of fluid over a period of time as well as for thepresence/detection of air.

In some embodiments, the fluid may pass through a hematocrit sensor 1004for measuring an amount of red blood cells or other cells suspended inthe fluid. In one embodiment, the tubing 1012 may comprise a hematocritsensor component 1024 for coupling with the hematocrit sensor 1004. Forexample, a section of tubing 1012 may contain a sensor “window” forinstalling into a hematocrit sensor (e.g., integrated in an agitatordevice cabinet), allowing the hematocrit sensor to transmit light energyinto the tubing for use in analyzing the fluid. In some embodiments,based on the amount of light that is reflected the hematocrit sensor1004 and/or a controller device may calculate a value and a saturationof hemoglobin in the fluid.

In one embodiment, the hematocrit sensor 1002 and/or flow/air detector1002 may be in communication with a processor of the cell resuspensioncontroller device 711, such as for transmitting measurements taken ofthe fluid to the processor (e.g., for display via user control panel 710and/or other user interface). Some embodiments may comprise storingand/or transmitting an indication of information determined using one ormore sensors described in this disclosure (e.g., a controller device maytransmit the information to a data storage device via a communicationsnetwork).

As shown in FIG. 10, the cell resuspension system 700, according to someembodiments, may also comprise at least one bar code scanner 1010 (e.g.,a USB barcode scanner by Unitech), network interface 1006 (e.g., forreceiving and/or transmitting patient case information, fluidinformation, and/or cell information), and/or equipotential bindingposts 1008 to facilitate ensuring the electrical safety of a controllerdevice and/or agitator device (e.g., when in use around flammableanesthetics and gases like oxygen). In some embodiments, networkinterface 1006 may comprise a wireless communications adapter and/or awired network port for communicating with one or more computers via acommunications network (e.g., the Internet, a hospital's intranet).

As shown in FIG. 9 and in FIG. 10, various fluid intake and/or fluidoutput components may be mounted onto and/or removably attached to, orintegrated with, an apparatus or device (e.g., the cell resuspensioncontroller device 711). For example, IV bags may be hung on the side ofa controller device, tubing removably loaded into a roller pump that isintegrated with a controller device, a heat exchange element of inlettubing may be removably secured in a heating element integrated with acontroller device, and/or a portion of outlet tubing may be coupled witha flow/air detector and/or a hematocrit sensor affixed to a controllerdevice. It will be readily understood, however, that any one or more ofthe fluid system components described in this disclosure does not haveto be physically attached to a side or other portion of the cellresuspension controller device. For example, one or more of the pump, IVbags, tubing (e.g., other the portion of tubing that enters the cellresuspension controller device and/or soaking tub), sensors, and/orheating element may be free standing, configured with or as a separateapparatus or device, or otherwise not affixed to a side of a cellresuspension controller device or cell resuspension agitator device.

FIG. 11 depicts a top view of an example occlusion clamp assembly 1100according to one or more embodiments. Occlusion clamp assembly 1100 maybe useful, in accordance with some embodiments, for clamping fluidtubing (e.g., of fluid intake system 712 and/or fluid output system714). In one or more embodiments, the occlusion clamp assembly 1100comprises occlusion motor 1102 for driving and withdrawing occlusionstem 1104. Occlusion motor 1102 is configured to (i) drive occlusionstem 1104 (e.g., upon receiving a signal from a controller device) intotubing 1105 and into stem receiver 1106 to clamp tubing 1105 and stopthe flow of fluid (and/or other materials) through the tubing 1105; and(ii) withdraw occlusion stem 104 from tubing 1105 to allow for the flowof fluid through the tubing 1105. In some embodiments, occlusion clampassembly 1100 may comprise a striker plate assembly 1108 against whichthe drive occlusion stem 1104 compresses the tubing 1105.

As depicted in FIG. 11, the example occlusion clamp assembly 1100 may bemounted, for example, on a side, panel, or frame 1110 of a cellresuspension system (e.g., an exterior cabinet panel of a cellresuspension agitator device or cell resuspension controller device), toallow for controlling the flow of fluid passing via tubing into and/orout of the device.

FIG. 12 and FIG. 13 depict perspective views of an example connector1202 and an example connector 1300, respectively, of a cell resuspensionsystem, according to one or more embodiments. In some embodiments, theconnector 1202 may be connected to and/or integrated with a cellresuspension tub (not shown) of a cell resuspension tub system and maybe configured for coupling the cell resuspension tub to a cellresuspension agitator device (not shown) via connector 1300. As depictedin FIG. 12, connector 1202 may comprise a male connector configured of ashape appropriate for inserting into a correspondingly shaped femaleconnector of an agitator device (or vice versa). As shown in FIG. 12,the connector 1202 may comprise a tubing passageway 1206. In oneembodiment, the tubing passageway 1206 may allow for tubing to passthrough the connector 1202 and into a soaking tub (e.g., soaking tub202). As shown in FIG. 12, the connector 1202 also may comprise a tubingpassageway or channel 1204. Similarly, the connector 1300 may comprise atubing passageway or channel 1302. In one or more embodiments, asdepicted in FIG. 14, the tubing channel 1204 and tubing channel 1302 mayallow for tubing 1208 (e.g., y-type tubing connection 222) to pass intothe connector 1202 (from one or both sides) and/or through the tubingpassageway 1206 while the connector 1202 is coupled with correspondingconnector 1300 of FIG. 13. Accordingly, fluid may be allowed to passinto and/or out of a soaking tub while the tub is coupled via connector1202 to connector 1300 of a drive shaft assembly (e.g., of a motor orother type of agitator device) for rotating the soaking tub.

FIG. 15 is a perspective view of an alternative example connector 1500of an agitator device, according to one or more embodiments, forconnecting to a cell resuspension tub system. Similar to the exampleconnector 1300 (FIG. 13), example connector 1500 may comprise a tubingchannel 1502 for receiving a holding tubing securely when the connector1500 is coupled with a soaking tub. Although the example connector 1500is circular in shape, it will be readily understood in light of thisdisclosure that connectors may be configured in any of various shapesand/or sizes suitable for a desired implementation.

FIG. 16 depicts a cross-section view of an example cell resuspension tubsystem 1600 according to one or more embodiments. Cell resuspension tubsystem 1600 comprises a soaking tub 1602 and a rotating connector 1608for connecting the soaking tub 202 to a means for rotating the soakingtub 1602 (e.g., a drive shaft assembly connected to a motor). Theexample cell resuspension tub system 1600 comprises a clamp 1609 forpreventing leaks (e.g., a tie band cable clamp) and a y-type tubingconnection 1610 for connecting the soaking tub 1602, inlet tubing 1612,and outlet tubing 1614. In contrast to some other embodiments discussedin this disclosure, the y-type tubing connection 1610 is not secured tothe rotating connector 1608, allowing the soaking tub 1602 and they-type tubing connection 1610 to move independently of one another. Forexample, if the rotating connector 1608 is rotatably secured to arotating motor (e.g., not shown), the y-type tubing connection 1610 mayremain relatively still or unaffected even while the soaking tub 1602 isrotating or spinning.

FIG. 17 depicts a cross-section view of an example cell resuspension tubsystem 1700 according to one or more embodiments. Cell resuspension tubsystem 1700 comprises a soaking tub 1702 for reclaiming cells fromarticles 1712 in fluid 1710. In contrast to some other embodimentsdiscussed in this disclosure, cell resuspension tub system 1700 includesa fluid intake system 1706 for providing fluid 1710 (e.g., via PVCtubing from IV bag 1704) to soaking tub 1702 via the opening at the topof soaking tub 1702. In one example, fluid intake system 1706 maycomprise tubing and/or a fluid dispensing element 1708 for releasingfluid into the soaking tub 1702. As shown in FIG. 17, the fluiddispensing element 1708 may comprise one or more holes through whichfluid 1710 may enter from the tubing into the soaking tub 202. Also incontrast to some other embodiments discussed in this disclosure, cellresuspension tub system 1700 does not require fluid to be both input andoutput in the same manner. For example, as shown in FIG. 17, a fluidoutput system 1716 may draw fluid (e.g., bearing recovered cells) viatubing through the bottom of the soaking tub 1702 (e.g., and to a cellsaver device).

Alternatively, or in addition, in some embodiments, fluid may be inputto the soaking tub via another opening in the soaking tub (other than atop opening) and/or fluid may be added to the soaking tub through oneopening (e.g., through the bottom of soaking tub 1702), while fluidcontaining any covered cells is extracted (e.g., using a suction pumpdevice) through another opening of the soaking tub (e.g., via tubing outof the top opening).

D. Example Systems and Devices

The following describes an example integrated cell resuspensionappliance, referred to as the “Agitator,” configured to provide for oneor more of various functions described in this disclosure, in accordancewith one or more embodiments. None of the examples, configurations,and/or features described with respect to the Agitator are to beunderstood as necessarily limiting any embodiment of the presentinvention. Various other embodiments and examples are described in thisdisclosure, and others will be readily understood by those skilled inthe art in light of the descriptions in this disclosure.

According to the example implementation, the Agitator may be configuredas a mechanical device for receiving and moving a sterile, disposableand/or single-use soaking tub (and its associated tubing). In onevariation, the Agitator is 26 inches square by 32 inches tall, with anopening at the top, and rests upon a stand with a plurality of wheels.The example Agitator device has a clear plastic lid on a hinge, allowingthe lid to be open or closed depending on the cycle that is beingutilized (e.g., Open, Start, Fill, Spin, Agitate, or Drain). TheAgitator may be vented (e.g., sharing the same atmospheric pressure asthe surrounding environment), or not, as deemed desirable for aparticular implementation.

The example Agitator device comprises multiple control buttons and adisplay screen for displaying data, on the front of the Agitator. Casedata collection (e.g., collection of information related to a type ofprocedure, length of procedure, surgeon, patient identifier thatuniquely identifies a patient) and transmission may be accomplished viaeither a wireless card or a wired network port (e.g., located on therear of the device).

The example Agitator device comprises a female, multifaceted connectorthat receives and locks the underside of a disposable soaking tub, forrotating or otherwise agitating the soaking tub. The left side of theAgitator, for example, comprises a 4-inch diameter, occlusive, dualheaded roller pump with its heads at 180 degrees in opposition to eachother. The roller pump assembly may sit, by way of example, inside of ametallic raceway. On one side of the metallic raceway is a shapedindentation or socket; on the opposite side of the raceway is adifferently shaped indentation or socket.

The example Agitator device also may comprise an electrically heated,metallic heat exchange surface (e.g., on an inflow tubing channel), madeof a resistive coil under a metal surface designed to heat physiologicfluid via the principle of conduction.

According to the example embodiment, the Agitator device comprises atemperature thermistor and one or more buttons on a front surfaceallowing for user interface and control. On the right side of theexample Agitator are a combination flow sensor and air detector for useon the outflow tubing via a tubing channel (e.g., not more than 1 inchrecessed into the device), a powered automatic occlusion clamp (e.g.,controlled by the Agitator), and a hematocrit sensor. The Agitatordevice is powered by AC current and may or may not include a batterybackup.

According to one embodiment, a cell resuspension tub system may beembodied as a tubing kit comprising: a sterile soaking tub and tubingset, one or both of which may be individually wrapped; a sterile plasticlid cover or sleeve; a sterile plastic panel cover (e.g., self-adhesivefor affixing to a user control panel); a sterile accessory drain line;and/or one or more other items (e.g., sensors, pumps, heaters, etc.).

E. Processes

According to one example process in accordance with some embodiments,one or more users (e.g., nurses or other medical professionals in anoperating room) and/or one or more controller devices may perform one ormore of the following: setting up a cell resuspension system for use;reclaiming cells from surgical laundry via the cell resuspension system;and/or processing resuspended cells for autotransfusion (e.g., via acell saver system). According to some embodiments, a process forreclaiming cells from surgical laundry via a cell resuspension systemmay comprise one or more of: initiating and/or terminating a fluidfilling process; initiating and/or terminating an agitation process;initiating and/or terminating a fluid removal process; and/or disposingof one or more components of a used cell resuspension tub system.

According to some embodiments, setting up a cell resuspension system foruse may comprise one or more users performing one or more of thefollowing:

-   -   powering on the agitator device    -   opening a lid of the agitator device (e.g., manually, or using        an “Open” button of a user control panel)    -   passing a (sterile) soaking tub onto the surgical field    -   covering the lid with a sterile plastic lid cover    -   inserting or otherwise connecting the soaking tub with the        agitator device (e.g., by inserting the soaking tub into a        female connector at the bottom of the agitator device)    -   removing or otherwise disconnecting a soaking tub (e.g., a        previously used tub) from the agitator device    -   placing inlet tubing in the appropriate location for loading the        inlet tubing (e.g., off the corresponding side of the agitator        device)    -   placing outlet tubing in the appropriate location for loading        the outlet tubing    -   closing the lid (e.g., to maintain sterility of the soaking tub        and the inside of the agitator device)    -   loading the inlet tubing into a heat exchange element    -   loading the inlet tubing into a roller pump assembly    -   loading the outlet tubing through one or more of an occlusion        clamp, a flow sensor, and an air detector    -   removing one or more sterile caps from the ends of the tubing        set    -   attaching an IV bag spike into an IV bag of physiologic fluid    -   opening one or more tubing clamps (e.g., Roberts clamps)    -   connecting a sterile accessory drain line from the outlet tubing        to a cell saver machine    -   attaching a sterile, self-adhesive plastic cover to a user        control panel of the agitator device

Referring now to FIG. 18, a flow diagram of a method 1800, according toone or more embodiments is shown. The method 1800 will be describedherein as being performed by an integrated controller/agitator device.It should be noted, however, that in some embodiments one or more of thesteps of method 1800 may be performed by a controller device, while oneor more other steps may be performed by another type of device (e.g., acontroller device, a pump, a heater) and/or by a human user. Further anysteps described herein as being performed by a particular type devicemay, in some embodiments, be performed by a human.

According to some embodiments, the method 1800 may comprise providing afluid (e.g., physiologic suspension solution) into a cell resuspensiontub, at 1802. In one embodiment, providing the fluid may be performedmanually by a user and/or in response to an instruction from a user oractuation of a corresponding user control by a user (e.g., via a usercontrol panel or interface). In some embodiments, providing the fluidmay be initiated and/or performed automatically in response to a signalor other communication from a controller device (e.g., in response toexecuting software instructions, in response to receiving a fillinstruction from a user). As discussed with respect to variousembodiments in this disclosure, providing the fluid may compriseinitiating an automated fill process for transmitting fluid from a fluidsource (e.g., an IV bag) via a tubing system, and/or starting andcontrolling a pump device to fill a cell resuspension tub. As describedin this disclosure, the fluid may comprise a physiologic suspensionsolution that may include one or more agents.

The method 1800 may comprise, in some embodiments, agitating the cellresuspension tub (e.g., automatically) by an agitator device, at 1804.For example, as discussed with respect to various embodiments in thisdisclosure, agitating a cell resuspension tub (e.g., including fluid andsurgical laundry inserted by a user or otherwise received by a cellresuspension system) may comprise operating a motor to rotate orotherwise agitate a cell resuspension tub removably coupled to themotor. In one embodiment, a controller device may transmit a signal tostart a rotating motor. In some embodiments, agitating the cellresuspension tub may comprise agitating fluid and/or and at least oneitem of surgical laundry (e.g., bloody surgical sponges) in the cellresuspension tub.

The method 1800 may comprise, according to some embodiments, removingfluid from the cell resuspension tub, at 1806. In some embodiments,removing fluid may comprise removing at least a portion of the fluidprovided to the cell resuspension tub (at 1802) along with any cellsreleased from surgical laundry and resuspended in the fluid. In one ormore embodiments, the removed fluid may comprise physiologic suspensionsolution, resuspended cells, and/or at least one drug or other agent.Various embodiments for draining or otherwise removing fluid andrecovered cells from a tub are described in this disclosure.

According to some embodiments, the method 1800 may further comprise oneor more of: transmitting the removed fluid to at least one of a cellsaver and an autotransfusion device, and maintaining a desiredtemperature of fluid (e.g., within a predetermined temperature range)using a thermometer and/or heater. Maintaining a desired temperature mayinclude heating and/or monitoring fluid before it enters the cellresuspension tub, while it is in the tub, and/or after it is removedfrom the tub. In one example, fluid is maintained at approximately anormothermic temperature for the type of cells being recovered (e.g.,the normothermic temperature of 98.6F for human blood).

According to an illustrative and non-limiting example of a method of useof a cell resuspension system comprising an example integratedcontroller/agitator device and tub system or kit (comprising a soakingtub and corresponding tubing set), the example agitator device andsoaking tub are designed to work in concert with each other. Theagitator device is a reusable device and the soaking tub (with itscorresponding tubing set) is a disposable, single-use device. Theagitator device is designed, according to the non-limiting example, tobe set up and operated in a sterile operating room environment byoperating room personnel (e.g., a “scrub” nurse and/or a “circulating”nurse). Although described with respect to a single nurse, it will bereadily understood that respective steps may be performed by any numberof users. According to the example method, when the agitator device isto be used, the individually wrapped and sterile disposable soaking tuband tubing set are passed onto the sterile field to the “scrubbed” ORpersonnel for setup. The agitator device preferably is positioned nextto the surgical field and plugged into AC current by the circulatingnurse. A nurse, for example, may cover the lid with supplied sterileplastic lid cover, and also insert the soaking tub into a multifacetedfemale receiver at the bottom of the agitator device. The nurse may alsoplace the inlet side of the tubing off the appropriate side of theagitator device, place the outlet tubing off the appropriate side of theagitator device, and close the lid, as the inside of the device is nowsetup and sterile. A nurse may load the inlet tubing into a heatexchange surface of the agitator device and into a roller pump assembly,and load the outlet tubing through the occlusion clamp, flow sensor, airdetector, and hematocrit sensor of the agitator device. The sterile capon the end of the tubing set may be left on the tubing until the systemis ready for use.

Continuing with the illustrative example method of use, a nurse attachesIV bag spikes of the inlet tubing into a physiologic fluid IV bag andopens the tubing clamps (e.g., Roberts clamps). The nurse also attachesthe sterile accessory drain line to an operating room cell saver machineand attaches a sterile self-adhesive plastic button cover to an operatorpanel of the agitator device. Before, after, or contemporaneously withthe insertion (e.g., by a nurse) of at least one bloody surgical spongeinto the soaking tub, a nurse presses a “Fill” button of the agitatordevice that fills the soaking tub with an amount of physiologic solution(e.g., an amount approximately ⅔ of the total tub capacity,approximately 360 mls of fluid). If desired, additional soak volume maybe added to the soaking but by depressing and holding the fill buttonagain.

Continuing with the illustrative example method of use, a user presses a“Start” button of the agitator device, causing the lid to lock, themultifaceted receiver to attach to the underside of the soaking tub, anda drain clamp of the agitator device to occlude the tubing set. Themultifaceted receiver engages the tub and begins the agitation of thesponges. This agitation may continue for a period of time sufficient toliberate the blood from the sponge. The period of time may bepredetermined and the agitation may be terminate automatically by theagitator device. Alternatively, or in addition, the agitation processmay be terminated at any time manually by a user pressing a “Stop”button (e.g., of a user control panel). For instance, this may allow anoperator to place more bloody sponges in the agitator device (e.g., asthey are collected). Pressing a “Start” button again after a stopresumes a previously started cycle where it was terminated.

Continuing with the illustrative example method of use, after theprocess of agitating the soaking tub (e.g., after the completion of apreprogrammed cycle and/or upon actuation of a “Finish” button by auser), the agitator device may automatically sound an alert (e.g.,“cycle complete” alert) and/or open the closed occlusion clamp to allowthe bloody suspension fluid to drain from the vessel. In one example,the fluid is exposed to suction created by a cell saver or other device,in order to drain the tub. Once an air detector detects air in theoutlet tubing, the occlusion clamp again engages and occludes the outlettubing. In one example, the device may automatically (and/or at theinitiation of a user) “dry spin” the tub (e.g., for a three minutecycle) at a speed designed to further remove blood from the spongesthrough centrifugal motion. Once the air detector again (or still)detects air in the outlet tubing, indicating the tub is empty, theagitator device may cause the occlusion clamp to again engage andocclude the outlet tubing. The operator may press an “Option” button toopen the lid and may remove the processed sponges. Once the processedsponges are out of the soaking tub, the operator may again initiate afill function (e.g., by pressing a “Fill” button) to fill the soakingtub with physiologic solution, in preparation for more blood soakedsurgical sponges. If no additional sponges need to be washed (e.g., asurgical operation has been completed), the operator may “unload” thesoaking tub and tubing set (e.g., by disconnecting it from the agitatordevice). A nurse may dispose of the soaking tub and/or the tubing set(s)(e.g., in an appropriate biohazard container).

According to the illustrative example method, the integratedcontroller/agitator device may display case information via a displayscreen of the device. For example, the device may display one or moreof: a volume of physiologic solution used, a volume of bloody suspensionfluid out, a temperature of the fluid, a number of cycles processed,and/or an average hematocrit value of the suspension fluid.

F. Example Interfaces and Applications

One or more of the methods described in this disclosure may involve oneor more interface(s). One or more methods may include, in someembodiments, providing an interface through which a user may (i) submit,request, and/or receive information about a patient and/or cells(reclaimed and/or to be reclaimed) and/or (ii) initiate one or moresteps of a cell resuspension process.

In one hypothetical example, a program being executed by a processor(e.g., embodied in a cell resuspension controller device) initiates aprocess via a user interface to reclaim blood cells from bloody surgicallaundry. Information about different blood reclamation options may bereceived from a user via the user interface, and various types ofinformation about the processing, fluid involved in the resuspensionprocess, and/or recovered blood cells may be displayed and/or otherwiseoutput to the user via the user interface.

FIG. 19 illustrates an example interface 1900, according to one or moreembodiments, by which a user (e.g., a medical professional operating acell resuspension controller device of a cell resuspension system) mayinitiate various phases of a cell resuspension process to extract cells(e.g., red blood cells) from surgical sponges, instruments, organs,human and/or animal tissue, and/or other types of surgical articles.

Example elements of interface 1900 include a button 1902 to initiate aprocess of filling a soaking tub, a button 1904 to initiate a washingprocess to collect cells from surgical articles, a button 1906 to stopthe washing process, and a button 1908 to release and/or open a lid(e.g., lid 704 of example cell resuspension system 700). For example,pressing any of the buttons 1902, 1904, 1906, and/or 1908 may cause acontroller device (e.g., cell resuspension controller device 711) toperform the corresponding function (e.g., in accordance withcorresponding computer readable software instructions executable by aprocessor of the controller device).

Interface 1900 may further comprise one or more input controls 1910 forincreasing, decreasing, inputting, modifying, and/or selecting values,settings, and/or options by a user. In one example, input controls 1910may be configured as arrow buttons for moving between options and/orfields on the user interface. Although only two arrows are depicted inFIG. 19, it will be readily understood that any number of arrows (e.g.,left and right arrows) and/or types of input controls (e.g., buttons,pointer devices, keyboards, touchpads, arrow keys, etc.) may be used asdeemed desirable for a particular implementation. In some embodiments,any one or more of buttons 1912 may be configured to allow a user toassign one or more functions to the button(s).

In one embodiment, a user may have the ability to enter data using theinterface 1900 (e.g., via corresponding form fields), such as, withoutlimitation, case data, patient name, name(s) of a surgeon and/or othermedical personnel, an identifier that identifies a type of surgery, atype of drug (e.g., a drug or other agent added to a solution beingadded to a soaking tub), a concentration of drug, and an amount of drugused). In some embodiments, one or more types of information may beretrieved (e.g., by a controller device) from one or more remote dataservers.

In some embodiments, various types of information may be presented to auser via interface 1900. For example, as shown in FIG. 19, informationtransmitted to a user via interface 1900 may comprise, withoutlimitation, one or more of the following:

-   -   information related to a number of cell resuspension cycles        processed and/or scheduled    -   information related to a volume or other measure of fluid input        to a cell resuspension system (e.g., 1450 ml)    -   information related to a volume or other measure of fluid        recovered and/or processed by a cell resuspension system (e.g.,        2700 ml)    -   information related to a volume or other measure of cells (e.g.,        blood cells) lost from a patient (e.g., 1250 ml)    -   information related to a temperature of fluid being input to        and/or processed by a cell resuspension system (e.g., an average        temperature)    -   information related to a measure of resuspended cells per volume        of fluid (e.g., an average hematocrit (H CT) percentage level)    -   information related to a previous, current, and/or future status        or phase of a cell resuspension process (e.g., “Washing”,        “Complete”, “Lid open”, “Tub filling”)    -   information related to how long a previous, current, and/or        future status or phase of a cell resuspension process has taken        or will take (e.g., “Wash time remaining—150 seconds”)    -   current date and/or time information    -   information related to a patient (e.g., a patient whose blood is        being resuspended)

According to one embodiment, the volume salvaged from the contents of asurgical sponge or other article may be calculated as a differencebetween a volume of physiologic fluid in and a volume of physiologicsolution out. For example: 2700 ml (volume of bloody suspension solutionout)−1450 ml (volume of physiologic solution in)=1250 ml (volume ofreclaimed volume). In some cases, items such as surgical laundry may becontaminated with irrigation fluid or other types of fluids, and notsolely blood. Accordingly, in some embodiments, it may or may not bepossible to determine whether the additional volume removed from a cellresuspension tub includes not just blood or other types of recoveredcells, but also one or more fluids that were collected by the surgicallaundry and released during the cell resuspension process.

Although certain types of information are illustrated in the exampleinterface 1900, those skilled in the art will understand that theinterface 1900 may be modified in order to provide for additional typesof information (e.g., other patient information) and/or to remove someof the illustrated types of information, as deemed desirable for aparticular implementation.

Although interface 1900 is illustrated as a single interface, thoseskilled in the art will readily understand, in light of the presentdisclosure, that the features and information of the example interface,or a subset of such features and information, may be included in morethan one interface, control panel, screen display, or applicationwindow.

Additional Embodiments

According to some embodiments, systems, methods, and apparatus may beprovided for the autotransfusion of recovered blood, such as bloodreclaimed from surgical laundry and resuspended in a fluid in accordancewith various embodiments described in this disclosure. Autotransfusionwill be readily understood by those skilled in the art as a process bywhich a patient's own shed blood can be returned to that patient.Autotransfusion typically uses a system to acquire, process, andre-infuse shed blood volume by means of a suction style of collection.Some of the benefits of autotransfusion include a reduction in thepatient's immune reactivity related to the administration of allogeneicblood (a.k.a. bank blood), an elimination of the potential for an ABOincompatibility, an elimination of the risk of transmission of bloodborne diseases like Hepatitis, HIV/AIDS, Cytomegalovirus Virus (CMV),Crutchfield Jakobs Disease (CJD) among many others known or unknown.Autotransfusion also decreases the demand on the supply of bloodavailable for transfusions. According to some embodiments, a cellresuspension system may comprise and/or may transmit resuspended bloodto one or more autologous cell salvage devices or cell savers forprocessing and/or eventual re-infusion in a patient.

According to one or more embodiments, a device is provided for use inresuspending blood that is suspended in surgical laundry, wherein thedevice uses a physiologic solution to fill a vessel to extract blood. Insome embodiments, the device comprises a vessel and the device isconfigured to fill the vessel (e.g., via a filling mechanism) with asterile physiologic suspension solution. In one or more embodiments, thedevice may comprise a mechanism for controlling the filling of thevessel with a physiologic suspension solution and/or for controlling theemptying of the vessel. In one embodiment, the vessel is configured sothat bloody surgical laundry may be placed (e.g., by a user) in thevessel to soak in sterile physiologic suspension solution. In oneembodiment, the vessel of the example device is engaged in a mechanismfor agitating the vessel to liberate blood from surgical laundry. In oneembodiment, the device may include a drain line at the bottom of thevessel (e.g., to drain the blood saturated suspension fluid from thevessel).

According to some embodiments, neither agitating a cell resuspensiontub, fluid, and/or surgical articles, nor releasing or resuspendingcells from surgical articles, comprises the use of suction, a vacuum, orother type of negative pressure.

According to some embodiments, providing fluid to a soaking tub or othertype of cell resuspension tub may not involve a pump or like device. Forexample, fluid may be introduced manually (e.g., by a user) into asoaking tub.

Although numerous embodiments are described in this disclosure withrespect to surgical laundry, sponges, and other types of surgicalarticles, it will be readily understood, in light of the presentdisclosure, that various embodiments described in this disclosure may beconfigured for use with any of various types of objects an item ofclothing, paper, and/or a piece of glass) that may have collected orretained cells to be recovered.

In one embodiment, a heater configured to heat physiologic suspensionsolution or other type of fluid used in resuspending cells may beconfigured for heating the fluid directly or indirectly, such as byheating tubing, IV bags, and/or a cell resuspension tub.

Interpretation

Numerous embodiments are described in this patent application, and arepresented for illustrative purposes only. The described embodiments arenot, and are not intended to be, limiting in any sense. The presentlydisclosed invention(s) are widely applicable to numerous embodiments, asis readily apparent from the disclosure. One of ordinary skill in theart will recognize that the disclosed invention may be practiced withvarious modifications and alterations, such as structural, logical,software, and/or electrical modifications. Although particular featuresof the disclosed invention(s) may be described with reference to one ormore particular embodiments and/or drawings, it should be understoodthat such features are not limited to usage in the one or moreparticular embodiments or drawings with reference to which they aredescribed, unless expressly specified otherwise.

The present disclosure is neither a literal description of allembodiments nor a listing of features that must be present in allembodiments.

Neither the Title (set forth at the beginning of the first page of thisdisclosure) nor the Abstract (set forth at the end of this disclosure)is to be taken as limiting in any way the scope of the disclosedinvention(s).

Throughout the description and unless otherwise specified, the followingterms may include and/or encompass the example meanings provided below.These terms and illustrative example meanings are provided to clarifythe language selected to describe embodiments both in the specificationand in the appended claims, and accordingly, are not intended to belimiting.

The terms “an embodiment”, “embodiment”, “embodiments”, “theembodiment”, “the embodiments”, “one or more embodiments”, “someembodiments”, “one embodiment” and the like mean “one or more (but notall) disclosed embodiments”, unless expressly specified otherwise.

The terms “the invention” and “the present invention” and the like mean“one or more embodiments of the present invention.”

A reference to “another embodiment” in describing an embodiment does notimply that the referenced embodiment is mutually exclusive with anotherembodiment (e.g., an embodiment described before the referencedembodiment), unless expressly specified otherwise.

The terms “including”, “comprising” and variations thereof mean“including but not limited to”, unless expressly specified otherwise.

The terms “a”, “an” and “the” mean “one or more”, unless expresslyspecified otherwise.

The term “plurality” means “two or more”, unless expressly specifiedotherwise.

The term “herein” means “in the present disclosure, including anythingwhich may be incorporated by reference”, unless expressly specifiedotherwise.

The phrase “at least one of”, when such phrase modifies a plurality ofthings (such as an enumerated list of things) means any combination ofone or more of those things, unless expressly specified otherwise. Forexample, the phrase at least one of a widget, a car and a wheel meanseither (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car,(v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, acar and a wheel.

The phrase “based on” does not mean “based only on”, unless expresslyspecified otherwise. In other words, the phrase “based on” describesboth “based only on” and “based at least on”.

Where a limitation of a first claim would cover one of a feature as wellas more than one of a feature (e.g., a limitation such as “at least onewidget” covers one widget as well as more than one widget), and where ina second claim that depends on the first claim, the second claim uses adefinite article “the” to refer to the limitation (e.g., “the widget”),this does not imply that the first claim covers only one of the feature,and this does not imply that the second claim covers only one of thefeature (e.g., “the widget” can cover both one widget and more than onewidget).

Each process (whether called a method, algorithm or otherwise)inherently includes one or more steps, and therefore all references to a“step” or “steps” of a process have an inherent antecedent basis in themere recitation of the term “process” or a like term. Accordingly, anyreference in a claim to a “step” or “steps” of a process has sufficientantecedent basis.

When an ordinal number (such as “first”, “second”, “third” and so on) isused as an adjective before a term, that ordinal number is used (unlessexpressly specified otherwise) merely to indicate a particular feature,such as to distinguish that particular feature from another feature thatis described by the same term or by a similar term. For example, a“first widget” may be so named merely to distinguish it from, e.g., a“second widget”. Thus, the mere usage of the ordinal numbers “first” and“second” before the term “widget” does not indicate any otherrelationship between the two widgets, and likewise does not indicate anyother characteristics of either or both widgets. For example, the mereusage of the ordinal numbers “first” and “second” before the term“widget” (1) does not indicate that either widget comes before or afterany other in order or location; (2) does not indicate that either widgetoccurs or acts before or after any other in time; and (3) does notindicate that either widget ranks above or below any other, as inimportance or quality. In addition, the mere usage of ordinal numbersdoes not define a numerical limit to the features identified with theordinal numbers. For example, the mere usage of the ordinal numbers“first” and “second” before the term “widget” does not indicate thatthere must be no more than two widgets.

As used in this disclosure, a “user” may generally refer to anyindividual and/or entity that operates a user device.

Some embodiments may be associated with a “user device” or a “networkdevice”. As used in this disclosure, the terms “user device” and“network device” may be used interchangeably and may generally refer toany device that can communicate via a network. Examples of user ornetwork devices include a personal computer (PC), a workstation, aserver, a printer, a scanner, a facsimile machine, a copier, a personaldigital assistant (PDA), a storage device (e.g., a disk drive), a hub, arouter, a switch, and a modem, a video game console, or a wirelessphone. User and network devices may comprise one or more communicationor network components.

As used in this disclosure, the terms “information” and “data” may beused interchangeably and may refer to any data, text, voice, video,image, message, bit, packet, pulse, tone, waveform, and/or other type orconfiguration of signal and/or information. Information may compriseinformation packets transmitted, for example, in accordance with theInternet Protocol Version 6 (IPv6) standard as defined by “InternetProtocol Version 6 (IPv6) Specification” RFC 1883, published by theInternet Engineering Task Force (IETF), Network Working Group, S.Deering et al. (December 1995). Information may, according to someembodiments, be compressed, encoded, encrypted, and/or otherwisepackaged or manipulated in accordance with any method that is or becomesknown or practicable.

In addition, some embodiments described in this disclosure areassociated with an “indication”. The term “indication” may be used torefer to any indicia and/or other information indicative of orassociated with a subject, item, entity, and/or other object and/oridea. As used in this disclosure, the phrases “information indicativeof” and “indicia” may be used to refer to any information thatrepresents, describes, and/or is otherwise associated with a relatedentity, subject, or object. Indicia of information may include, forexample, a code, a reference, a link, a signal, an identifier, and/orany combination thereof and/or any other informative representationassociated with the information. In some embodiments, indicia ofinformation (or indicative of the information) may be or include theinformation itself and/or any portion or component of the information.In some embodiments, an indication may include a request, asolicitation, a broadcast, and/or any other form of informationgathering and/or dissemination.

“Determining” something may be performed in a variety of manners andtherefore the term “determining” (and like terms) includes calculating,computing, deriving, looking up (e.g., in a table, database or datastructure), ascertaining, recognizing, and the like.

A “processor” means any one or more microprocessors, Central ProcessingUnit (CPU) devices, computing devices, microcontrollers, digital signalprocessors, or like devices. Examples of processors include, withoutlimitation, INTEL's PENTIUM, AMD's ATHLON, or APPLE's A6 processor.

When a single device or article is described in this disclosure, morethan one device or article (whether or not they cooperate) mayalternatively be used in place of the single device or article that isdescribed. Accordingly, the functionality that is described as beingpossessed by a device may alternatively be possessed by more than onedevice or article (whether or not they cooperate). Where more than onedevice or article is described in this disclosure (whether or not theycooperate), a single device or article may alternatively be used inplace of the more than one device or article that is described. Forexample, a plurality of computer-based devices may be substituted with asingle computer-based device. Accordingly, functionality that isdescribed as being possessed by more than one device or article mayalternatively be possessed by a single device or article. Thefunctionality and/or the features of a single device that is describedmay be alternatively embodied by one or more other devices that aredescribed but are not explicitly described as having such functionalityand/or features. Thus, other embodiments need not include the describeddevice itself, but rather can include the one or more other devices thatwould, in those other embodiments, have such functionality/features.

A description of an embodiment with several components or features doesnot imply that any particular one of such components and/or features isrequired. On the contrary, a variety of optional components aredescribed to illustrate the wide variety of possible embodiments of thepresent invention(s). Unless otherwise specified explicitly, nocomponent and/or feature is essential or required.

Further, although process steps, algorithms or the like may be describedor depicted in a sequential order, such processes may be configured towork in one or more different orders. In other words, any sequence ororder of steps that may be explicitly described or depicted does notnecessarily indicate a requirement that the steps be performed in thatorder. The steps of processes described in this disclosure may beperformed in any order practical. Further, some steps may be performedsimultaneously despite being described or implied as occurringnon-simultaneously (e.g., because one step is described after the otherstep). Moreover, the illustration of a process by its depiction in adrawing does not imply that the illustrated process is exclusive ofother variations and modifications, does not imply that the illustratedprocess or any of its steps is necessary to the invention, and does notimply that the illustrated process is preferred.

It will be readily apparent that the various methods and algorithmsdescribed in this disclosure may be implemented by, e.g., appropriately-and/or specially-programmed general purpose computers and/or computingdevices. Typically a processor (e.g., one or more microprocessors) willreceive instructions from a memory or like device, and execute thoseinstructions, thereby performing one or more processes defined by thoseinstructions. Further, programs that implement such methods andalgorithms may be stored and transmitted using a variety of media (e.g.,computer-readable media) in a number of manners. In some embodiments,hard-wired circuitry or custom hardware may be used in place of, or incombination with, software instructions for implementation of theprocesses of various embodiments. Thus, embodiments are not limited toany specific combination of hardware and software.

Accordingly, a description of a process likewise describes at least oneapparatus for performing the process, and likewise describes at leastone computer-readable medium and/or computer-readable memory forperforming the process. The apparatus that performs a described processmay include components and/or devices (e.g., a processor, input andoutput devices) appropriate to perform the process. A computer-readablemedium may store program elements and/or instructions appropriate toperform a described method.

The term “computer-readable medium” refers to any medium thatparticipates in providing data (e.g., instructions or other information)that may be read by a computer, a processor, or a like device. Variousforms of computer-readable media may be involved in carrying data,including sequences of instructions, to a processor. For example,sequences of instruction (i) may be delivered from RAM to a processor,(ii) may be carried over a wireless transmission medium, and/or (iii)may be formatted according to any one or more of various known formats,standards, or protocols (some examples of which are described in thisdisclosure with respect to communication networks).

Computer-readable media may take many forms, including but not limitedto, non-volatile media, volatile media, and transmission media.Non-volatile media may include, for example, optical or magnetic disksand other types of persistent memory. Volatile media may include, forexample, DRAM, which typically constitutes the main memory for acomputing device. Transmission media may include, for example, coaxialcables, copper wire, and fiber optics, including the wires that comprisea system bus coupled to the processor. Transmission media may include orconvey acoustic waves, light waves, and electromagnetic emissions, suchas those generated during RF and IR data communications. Common forms ofcomputer-readable media include, for example, a floppy disk, a flexibledisk, a hard disk, magnetic tape, any other magnetic medium, a CD-ROM,DVD, any other optical medium, a punch card, paper tape, any otherphysical medium with patterns of holes, a RAM, a PROM, an EPROM, aFLASH-EEPROM, a Universal Serial Bus (USB) memory stick or thumb drive,a dongle, any other memory chip or cartridge, a carrier wave, or anyother medium from which a computer can read.

The term “computer-readable memory” may generally refer to a subsetand/or class of non-transitory computer-readable medium that does notinclude intangible or transitory signals, waves, waveforms, carrierwaves, electromagnetic emissions, or the like. Computer-readable memorymay typically include physical, non-transitory media upon which data(e.g., instructions or other information) are stored, such as optical ormagnetic disks and other persistent memory, DRAM, a floppy disk, aflexible disk, hard disk, magnetic tape, any other magnetic medium, aCD-ROM, DVD, any other optical medium, punch cards, paper tape, anyother physical medium with patterns of holes, a RAM, a PROM, an EPROM, aFLASH-EEPROM, USB devices, any other memory chip or cartridge, and thelike.

Where databases are described, it will be understood by one of ordinaryskill in the art that (i) alternative database structures to thosedescribed may be readily employed, and (ii) other memory structuresbesides databases may be readily employed. Any illustrations ordescriptions of any sample databases presented in this disclosure areillustrative arrangements for stored representations of information. Anynumber of other arrangements may be employed besides those suggested by,e.g., tables illustrated in drawings or elsewhere. Similarly, anyillustrated entries of the databases represent exemplary informationonly; one of ordinary skill in the art will understand that the numberand content of the entries may be different from those described in thisdisclosure. Further, despite any depiction of the databases as tables,other formats (including relational databases, object-based models,hierarchical electronic file structures, and/or distributed databases)could be used to store and/or manipulate the described data. Likewise,object methods or behaviors of a database may be used to implement oneor more of various processes, such as those described in thisdisclosure. In addition, the databases may, in a known manner, be storedlocally and/or remotely from a device that accesses data in such adatabase. Furthermore, while unified databases may be contemplated, itis also possible that the databases may be distributed and/or duplicatedamongst a variety of devices.

The present disclosure provides, to one of ordinary skill in the art, anenabling description of several embodiments and/or inventions. Some ofthese embodiments and/or inventions may not be claimed in the presentapplication, but may nevertheless be claimed in one or more continuingapplications that claim the benefit of priority of the presentapplication. Applicants intend to file additional applications to pursuepatents for subject matter that has been disclosed and enabled but notclaimed in the present application.

1. A cell resuspension system comprising: a soaking tub comprising: atleast one fin connected to an interior portion of the soaking tub, afirst connector connected to a bottom portion of the soaking tub, thefirst connector being configured for rotatably coupling with an agitatordevice, the first connector having a passageway configured for receivingtubing through the first connector, and a filter disposed in the soakingtub and configured to filter physiologic suspension solution beingremoved from the soaking tub; a fluid intake system configured forproviding physiologic suspension solution into the soaking tub, thefluid intake system comprising: inlet tubing connected to the soakingtub via the passageway of the first connector, at least one deviceconnected to the inlet tubing and configured to control flow ofphysiologic suspension solution through the inlet tubing into thesoaking tub, and a first heater connected to the inlet tubing andconfigured to heat physiologic suspension solution in the inlet tubing;a fluid output system configured for removing physiologic suspensionsolution from the soaking tub, the fluid output system comprising:outlet tubing connected to the soaking tub via the passageway of thefirst connector; an agitator device configured to agitate the soakingtub by rotating the soaking tub back and forth, the agitator devicecomprising: a motor, and a second connector connected to the motor andconfigured for rotatably coupling with the first connector of thesoaking tub; and a controller device configured to: control operation ofthe at least one device configured to control flow of physiologicsuspension solution through the passageway into the soaking tub, controlthe first heater to heat physiologic suspension solution, controloperation of the agitator device to agitate the soaking tub, and controloperation of the fluid output system to remove, from the soaking tub viathe passageway, physiologic suspension solution that includesresuspended cells released from surgical laundry.
 2. (canceled)
 3. Thecell resuspension system of claim 1, the fluid input system furthercomprising at least one of: an IV bag spike connected to the inlettubing, a heat exchange element integrated in the inlet tubing, atemperature sensor connected to the inlet tubing, and at least onetubing guide connected to the inlet tubing and configured to be insertedin a correspondingly shaped socket of the cell resuspension system toensure loading of the inlet tubing in a predetermined direction.
 4. Thecell resuspension system of claim 1, the fluid output system comprisingat least one of: a hematocrit sensor connected to the outlet tubing andconfigured to measure a hematocrit value for physiologic suspensionsolution removed from the soaking tub, a flow sensor connected to theoutlet tubing and configured to measure a volume of physiologicsuspension solution removed from the soaking tub, and an air detectorconnected to the outlet tubing and configured to detect air inphysiologic suspension solution removed from the soaking tub. 5-6.(canceled)
 7. The cell resuspension system of claim 1, the soaking tubfurther comprising: a fill sensor configured to detect fluid in thesoaking tub; and the controller device being further configured to:receive a signal from the fill sensor, the signal indicating detectionof physiologic suspension solution in the soaking tub, and in responseto receiving the signal, automatically control operation of the at leastone device configured to control flow of physiologic suspension solutionto terminate flow of physiologic suspension solution into the soakingtub.
 8. The cell resuspension system of claim 1, the controller devicebeing further configured to: receive a signal from at least one of aflow sensor and an air detector, the signal indicating an absence offluid in the outlet tubing; and in response to receiving the signal,automatically control operation of the at least one device configured tocontrol flow of physiologic suspension solution to terminate removal ofphysiologic suspension solution from the soaking tub via the fluidoutput system.
 9. The cell resuspension system of claim 1, wherein thesoaking tub further comprises: a first wall and a second wall inside thefirst wall, the second wall including at least one fenestration forallowing physiologic suspension solution to pass through the second wallfrom the interior portion of the soaking tub.
 10. The cell resuspensionsystem of claim 1, wherein the agitator device further comprises atleast one of: a power supply connected to the motor, and a drive shaftconnected to the second connector and configured for rotating the secondconnector and the first connector when the second connector is rotatablycoupled to the first connector.
 11. The cell resuspension system ofclaim 1, further comprising: a lid for controlling access to theinterior portion of the soaking tub.
 12. The cell resuspension system ofclaim 12, further comprising a sterile sleeve configured to slide overthe lid.
 13. The cell resuspension system of claim 1, further comprisinga user control panel for controlling at least one function of thecontroller device.
 14. The cell resuspension system of claim 13, furthercomprising a user control panel covering for maintaining sterility ofthe user control panel.
 15. A method comprising: providing a physiologicsuspension solution into a cell resuspension tub through a firstconnector connected to a bottom portion of the cell resuspension tub;agitating, automatically via an agitator device comprising a secondconnector, the cell resuspension tub while the second connector isremovably coupled to the first connector, the cell resuspension tubincluding the physiologic suspension solution and at least one item ofsurgical laundry, the at least one item of surgical laundry retainingcells to be resuspended; and removing, from the cell resuspension tubthrough the first connector while the first connector is removablycoupled to the second connector, a solution including at least a portionof the physiologic suspension solution and resuspended cells releasedfrom the at least one item of surgical laundry.
 16. The method of claim15, further comprising: transmitting the removed solution to at leastone of: a cell salvage device and an autotransfusion device. 17.(canceled)
 18. A cell resuspension tub kit comprising: a sterile cellresuspension tub comprising: a connector connected to a bottom portionof the sterile cell resuspension tub, the connector being configured forcoupling with an agitator device, the connector having a passagewayconfigured for allowing fluid to pass through the connector, and afilter disposed in the connector and configured to filter fluid exitingthe sterile cell resuspension tub through the connector; a heat exchangeelement; and a length of sterile tubing.
 19. The cell resuspension tubkit of claim 18, further comprising at least one of the following: asterile lid sleeve; and a sterile panel cover.
 20. The cell resuspensiontub kit of claim 18, further comprising at least one of the following:physiologic fluid; a sterile accessory drain line; and a sensor.
 21. Thecell resuspension system of claim 1, further comprising: physiologicsuspension solution.
 22. The cell resuspension system of claim 1,wherein the first connector comprises a y-type tubing connection that isdisposed in the passageway.
 23. The cell resuspension system of claim22, wherein the y-type tubing connection is connected to the inlettubing and to the outlet tubing.
 24. The cell resuspension system ofclaim 1, wherein the second connector comprises a channel configured tosecure, when the second connector is rotatably coupled to the firstconnector, at least one of: the inlet tubing, the outlet tubing, and ay-type tubing connection connected to the inlet tubing and to the outlettubing.
 25. The method of claim 15, wherein agitating the cellresuspension tub comprises rotating the cell resuspension tub back andforth.